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	Arrhythmia (1721)
Date of Event	10/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During treatment for third-degree atrioventricular block, bradycardia occurred requiring medication administration to stabilize the patient.A temporary pacemaker was placed via the right femoral artery.Later that morning, the ecg monitor alarmed indicating bradycardia.Upon inspection, the connection line of the temporary pacemaker catheter was noted to be broken.Medication was administered to treat the bradycardia, the patient stabilized and the catheter was removed.
Event or Problem Description
This report is to include the name of the physician involved in the reported event.
Additional Manufacturer Narrative
An image was submitted for evaluation to product performance engineering; no device components were returned.The ¿(+)¿ proximal leg 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 photograph provided.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 bradycardia device damage could not be conclusively 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: 18166767
• Report Number: 2182269-2023-00052
• Device Sequence Number: 12397362
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2024

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: 09/30/2025
• Device Model Number: 401771
• Device Lot Number: 8721173
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 12/20/2023
• Initial Report FDA Received Date: 11/18/2023
• Supplement Report FDA Received Date: 12/12/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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; Life Threatening
• Patient Sex: Unknown