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

Model Number	401770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Death
Event or Problem Description
After using the temporary pacing catheter, the patient expired.The cause of death remains uncertain.
Additional Manufacturer Narrative
Additional information: h6: one 6f pacel bipolar pacing catheter (torque control) was received for analysis.Electrical testing revealed both the tip and ring electrode circuits met specifications of acceptable resistance values with no open or short circuits detected.The catheter shaft outside diameter measurement was within specifications.No resistance and no anomalies were noted when the returned catheter was inserted through a 6f sheath from current inventory.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported patient death remains unknown.

• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20398290
• Report Number: 2182269-2024-00036
• Device Sequence Number: 12391491
• Product Code: LDF
• UDI-Device Identifier: 05414734001113
• UDI-Public: (01)05414734001113(10)9106265(17)260531
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 05/31/2026
• Device Model Number: 401770
• Device Catalogue Number: 401770
• Device Lot Number: 9106265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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: Death
• Patient Sex: Unknown