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

Model Number 401771

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

Patient Problems Perforation (2001); Cardiac Perforation (2513)

Event Date 03/16/2022

Event Type  Injury  

Event Description

Related manufacturing ref: 2182269-2022-00021.During a percutaneous valve procedure, two epicardial perforations occurred.The patient became unstable immediately after insertion of the pacing catheter and experienced bradycardia and another transitory pacing catheter was used.An echocardiogram was performed which revealed two epicardial perforations.The patient was taken to surgery for repair and is unstable in the icu.There were no performance issues with the catheter.

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 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; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13918818
• MDR Text Key: 288866734
• Report Number: 2182269-2022-00020
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 7728340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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
• Treatment: PACEL BIPOLAR PACING CATHETER.
• Patient Outcome(s): Required Intervention