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

Model Number	401771
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/14/2024
Type of Reportable Event	Death
Event or Problem Description
During a transcatheter aortic valve implantation (tavi) procedure, a cardiac perforation occurred leading to the patient expiring one day post procedure.On (b)(6) 2024, a temporary pacemaker was implanted during the valve implant procedure and connected to an external pacemaker generator, confirming correct operation.The patient was then transferred to the icu.The following day, the patient experienced hemodynamic decompensation and was diagnosed with cardiac tamponade secondary to a perforation at the site of the pacel.The patient was transferred to surgery for a pericardial window procedure, however, the patient expired.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported cardiac perforation and subsequent death remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During a transcatheter aortic valve implantation (tavi) procedure, a cardiac perforation occurred, and the patient expired one day post procedure.On (b)(6) 2024, a pacel catheter was placed during the valve implant procedure and connected to an external pacemaker generator.The catheter was placed without any difficulty.Following the procedure, the patient was transferred to the icu.The following day, the patient experienced hemodynamic decompensation and was diagnosed with cardiac tamponade secondary to a perforation at the site of the pacel (anterior surface of the right ventricle).The patient was transferred to surgery for a pericardial window procedure, however the patient expired.There were no product performance issues with any abbott device.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL HEA; 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: 20707527
• Report Number: 2182269-2024-00041
• Device Sequence Number: 13171254
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: (01)05414734001137(10)8858013(17)251231
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K152784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 12/18/2024

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: 12/31/2025
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 8858013
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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