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

Model Number 401674

Device Problem Loss of Threshold (1633)

Patient Problem Cardiac Arrest (1762)

Event Date 04/13/2021

Event Type  Injury  

Event Description

During a pacemaker lead removal procedure in a patient with complete av block, the catheter was inserted into right ventricular for backup pacing.The catheter paced intermittently and when the permanent lead was removed, the catheter did not pace resulting in 15 seconds of asystole.The catheter was replaced with a non-abbott device and the procedure was completed with no further consequences to the patient.

Manufacturer Narrative

One 5f pacel bipolar pacing catheter was received for analysis.The results of the investigation concluded there were intermittent signals and high resistance between the ring electrode and proximal (+) connector pin, however, the cause of the intermittent and high resistance could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the pacing issue is consistent with the intermittent signals and high resistance.The cause of the intermittent signals and high resistance remains unknown.

• 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
• MDR Report Key: 11812846
• MDR Text Key: 250226603
• Report Number: 2182269-2021-00037
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 401674
• Device Lot Number: 7385411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other