MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL BIPOLAR PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	401771
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	12/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure conducted to treat a third degree atrioventricular block that the patient had prior to the procedure, due to a malfunction with the pacing catheter and not being able to use the device, the patient had to be given an intravenous drip of isoproterenol.Initially a pacing catheter was wanted to be used for intracardiac pacing to help increase the patient's heart rate.During application, it was found that the connection between the red negative electrode and the pacemaker was separated.Moreover, the outer coating of the wire detached from the internal wire and red electrode.The patient was immediately given an intravenous drip of isoproterenol, and the temporary pacemaker electrode was replaced for heart rate elevation.There were no adverse consequences to the patient due to the fracture of the connection between the red negative electrode and the pacemaker.The patient's third degree atrioventricular block was able to be treated and the patient was noted to be stable.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.Two images were submitted for evaluation to product performance engineering; no device components were returned.The photos appeared to show a 6f pacel bipolar pacing catheter.The braid wire appeared to have fractured near the bifurcation area, resulting in wire exposure and separation of the leg wire tubing from the connector pin assembly.Visual inspection was based solely upon a review of the photographs provided.The device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported wire detachment could not be determined.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13258442
• Report Number: 2182269-2022-00002
• Device Sequence Number: 4761282
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 7728340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown