MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL BIPOLAR PACING CATHETER; TEMPORARY CARDIAC PACING CATHETER

Model Number 401771

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

Patient Problems Cardiac Perforation (2513); Heart Block (4444)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history records for each possible batch number (8670542 or 8462657) were 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.

Event Description

The patient underwent implantation of an aortic valve prosthesis (tavi).At the end of the procedure, a moderate pericardial effusion with hemodynamic compromise was observed, and at the time the patient was submitted to a ct-guided pericardiocentesis.The day after the procedure, with a complete av block of sudden onset and with hemodynamic compromise.A temporary transvenous pacemaker was placed through the femoral vein, which was removed the next day, after placement of a permanent pacemaker.With the removal of the provisional pace, there was a new pericardial effusion with hemodynamic compromise, presuming right ventricular perforation.The patient had to be taken to the operating room for drainage and resolution of any perforation.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Type of Device: TEMPORARY CARDIAC PACING CATHETER
• 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: 17432724
• MDR Text Key: 320115417
• Report Number: 2182269-2023-00039
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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
• Report Date: 07/31/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other; Life Threatening