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

Model Number 401763

Device Problems Failure to Capture (1081); Loss of Threshold (1633)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The results, method and conclusion codes, along with investigation results will be provided in the final report.

Event Description

During tavr procedure, while rc pacing, there was loss of capture resulting in a new valve having to be redeployed.Troubleshooting included replacing the remington cables, but the issue persisted.The device was replaced, and the issue was resolved.Due to this event a new valve had to be redeployed.

Manufacturer Narrative

One 5f pacel bipolar pacing catheter (flow direct) was received for analysis.The results of the investigation concluded that there were no shorted, crossed, or intermittently open circuits.The measured resistance values for both the tip and ring electrode circuits were within specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 10894886
• MDR Text Key: 217968229
• Report Number: 2182269-2020-00110
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: 05414734007856
• Combination Product (y/n): N
• PMA/PMN Number: K161873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 7599845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other