MAUDE Adverse Event Report: COOK INC. COOK MEDICAL NEEDLE'S EYE SNARE; CATHETER, EMBOLECTOMY

Device Problems Entrapment of Device (1212); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problems Adhesion(s) (1695); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2023

Event Type  Death  

Event Description

In accordance with title 21 part 803, subpart b, 803.22(b)(2), this letter is to notify and provide you the information philips received on 06 nov 2023 which reported that during a lead extraction procedure, the right ventricular (rv) lead began to break apart while traction was being applied using a cook medical needle's eye snare.The next day, the patient suffered a stroke and died; posthumously, a lead fragment was detected in the patient's brain.Although a spectranetics device was in use during the time of the lead extraction procedure, the lead did not begin to break apart until traction was being applied from the needle's eye snare.Lead extraction indication: removing a right atrial (ra) and a right ventricular (rv) lead due to cied(cardiovascular implantable electronic devices) system/pocket infection and adhesions.The plan was to keep any devices out of the superior vena cava (svc) region due to the patient's age and infection.Ra lead removed successfully (spectranetics glidelight laser sheath used only in clavicle region).Attempted to remove the rv lead using a cook medical needle's eye snare as the traction platform, glidelight only went to the clavicular region, and then was not used any further.The rv lead seemed attached (adhesions) down the vasculature.Traction only was applied via the snare, with the patient's blood pressure dropping occasionally during traction, recovering once the traction was released.During the traction attempts, the rv lead began breaking apart, and breaking up fibrous tissue as well.Once the lead began to fall apart, snaring attempts were discontinued and the procedure concluded, with the rv lead still remaining in the patient.The patient survived the initial procedure.The next day, the patient suffered a stroke and died.Posthumously, a lead fragment was detected in the patient's brain.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

Event Description

Additional information received on 12/01/2023 for report mw5148557 to change procode to dxe.

• Brand Name: COOK MEDICAL NEEDLE'S EYE SNARE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): COOK INC.
• MDR Report Key: 18238255
• MDR Text Key: 329475330
• Report Number: MW5148557
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: RIGHT ATRIAL(RA)/RIGHT VENTRICULAR(RV) LEAD
• Patient Outcome(s): Death
• Patient Age: 86 YR