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

Model Number 401769

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 10/01/2019

Event Type  Injury  

Event Description

The patient presented to the emergency room and needed to have an external pacing lead.A 5 or 6 f was not available, so a 4 f was used.The patient was experiencing symptoms, and an echo confirmed that the device was perforating the apex.The patient was transferred to a different hospital, and a sternotomy was performed to withdraw the lead.

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 remains unknown.

• 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 (CVD-MINNETONKA); 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9259980
• MDR Text Key: 164423779
• Report Number: 2182269-2019-00191
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734027281
• UDI-Public: 05414734027281
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K875059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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 Expiration Date: 04/30/2022
• Device Model Number: 401769
• Device Catalogue Number: 401769
• Device Lot Number: 7000868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• 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): Other; Required Intervention