MAUDE Adverse Event Report: ST. JUDE MEDICAL 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	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a temporary pacing electrode implantation procedure, a pericardial effusion occurred requiring medication administration to stabilize the patient.Access was obtained via the left femoral vein and a venous sheath was inserted.A temporary electrode was placed in the right ventricle and a temporary pacemaker was connected.The pacing frequency was set to 60 times/min and the pacing voltage was set.Is 5v, fixed electrode.After the temporary pacemaker was implanted, the heart ruptured and perforated and the patient suddenly suffered from confusion, circulatory collapse, and low blood pressure.An ultrasound was performed to diagnose the pericardial effusion.Pressor medications were administered to maintain blood pressure and the patient was transferred to a (b)(6) hospital and is currently in stable condition.The physician alleges the electrode tip was possibly hard and the cause of the perforation may have been due to high tension after electrode implantation.
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 incident could not be conclusively determined.Per the ifu, cardiac tamponade and endocardial perforation are known risks during the use of this device.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20232429
• Report Number: 2182269-2024-00029
• Device Sequence Number: 15612783
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: (01)05414734001137(10)9231613(17)260831
• 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): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 9231613
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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
• Patient Sex: Unknown