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

Model Number 401771

Device Problem Material Separation (1562)

Patient Problem Arrhythmia (1721)

Event Date 10/21/2023

Event Type  Injury  

Event 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 Description

This report is to include the name of the physician involved in the reported event.

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
• Type of Device: 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
• MDR Text Key: 328478033
• Report Number: 2182269-2023-00052
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/18/2023
• Supplement Dates Manufacturer Received: 10/30/2023; 12/20/2023
• Supplement Dates FDA Received: 12/12/2023; 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening