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Weitz & Luxenberg, P.C., today launched an investigation into injuries sustained by patients when catheters used during cardiac angiogram procedures to inject contrast dye into blood vessels malfunctioned by either splitting or separating.
The probe centers around one particular brand of angiographic catheters made by Cook Medical of Bloomington, Indiana. The recall, classified as a Class I recall by the FDA, notes these problems could “cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.”
A cardiac angiogram is an imaging procedure that allows doctors to measure and visualize blood flow within the heart. The America Heart Association (AHA) describes the procedure as typically having minimal side effects.
The Cook Medical Beacon Tip angiographic catheters at the center of the investigation have been reported to either split or break at the tip while inside the patient’s vasculature, the firm said.
W&L began its investigation after Cook Medical on July 2 recalled 38,895 domestically distributed units of its Beacon Tip Angiographic Catheters. The recalled catheters were distributed between June 2013 and June 2015.
The recalled products include the Beacon Tip Torcon NB Advantage Catheters (Cook Medical catalog prefix HNBR5.0), Beacon Tip Royal Flush Plus High-Flow Catheters (catalog prefix HNR4.0) and Slip-Cath Beacon Tip Catheters (SCBR5.0).
The voluntary recall was posted by the U.S. Food and Drug Administration (FDA) on August 7. The FDA explained the recall was precipitated by Cook Medical receiving 26 reports of catheter malfunctions, 14 of which involved adverse events.
“The consequences of a catheter malfunctioning inside a heart chamber or a blood vessel during an angiogram could be potentially devastating,” said Paul Pennock, managing attorney of W&L’s Defective Drugs and Devices unit.
“As defined by the FDA, a serious adverse event may mean that use of the medical product substantially disrupted the patient’s ability to conduct normal life functions, created a substantial risk of death at the time of the adverse event, or perhaps even resulted in death,” he added.
Exploring Injured Heart Patients’ Legal Rights
W&L said its investigation is for now focused on meeting with patients who were injured by Cook Medical Beacon Tip angiographic catheters.
W&L plans to meet with representatives of the estates of such patients who died as a result of being harmed by the Cook Medical Beacon Tip angiographic catheters.
The firm indicated that one purpose of these meetings will be to help the injured patients or their estates understand their legal rights to compensation from Cook Medical.
According to W&L, harm caused by a malfunctioning Cook Medical Beacon Tip angiographic catheter may give rise to a right to recover medical care expenses related to post-injury treatment.
The injured patients or their estates may also be entitled to recover lost wages if medical interventions to treat a Cook Beacon Tip angiographic catheter injury caused the patient to be absent from his or her place of employment or to be laid off.
The firm said it is also possible an injured patient or his or her estate may be able to receive compensation for other damages spawned by the malfunction of a Cook Beacon Tip angiographic catheter.
“If you were injured during a cardiac angiogram due to breakage of this device, or if loved ones suffered because of your injury, then you may have legal rights against Cook Medical,” said Ellen Relkin, of counsel attorney in W&L’s Defective Drugs and Devices unit.