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

Model Number	401763
Medical Device Problem Codes	Failure to Capture (1081); Loss of Threshold (1633)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results, method and conclusion codes, along with investigation results will be provided in the final report.
Event or Problem 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.
Additional 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
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 10894886
• Report Number: 2182269-2020-00110
• Device Sequence Number: 2895363
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: 05414734007856
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other