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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL PACEL FLOW DIRECTED PACING CATHETER ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 401762
Device Problem Detachment of Device or Device Component
Event Date 06/12/2019
Event Type  Injury  
Event Description

During a valvuloplasty procedure, the distal electrode on the catheter was left inside a peripheral vein. While the device was in the right atrium, the balloon was inflated and deflated. Later, the balloon was attempted to be inflated, however, x-ray revealed that the balloon was not inflated. While extracting the device, the electrode was noted to be missing and the device was damaged. An x-ray showed that the distal electrode was not in the heart but a peripheral vein, so the procedure was completed and the electrode was not retrieved. There were no patient consequences and no intervention was performed.

 
Manufacturer Narrative

One pacel flow directed pacing catheter was returned to the manufacturer for analysis. The reported event of a balloon inflation issue and detached distal electrode was confirmed. The results of the investigation concluded that the balloon was undamaged, and the distal and proximal adhesive bonds were intact; however, the distal tip electrode had been detached and was not returned. Although functional testing for the balloon inflation difficulties could not be conducted, the cause of the balloon inflation difficulties is consistent with the detached distal tip electrode. Additional investigation concluded the cause of the detached tip electrode was due to incorrectly mixed epoxy.

 
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Brand NamePACEL FLOW DIRECTED PACING CATHETER
Type of DeviceELECTRODE, 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
stephanie o' sullivan
5050 nathan lane north
plymouth , MN 55442
6517565400
MDR Report Key8728639
Report Number2182269-2019-00083
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device MODEL Number401762
Device Catalogue Number401762
Device LOT Number6808401
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/24/2019 Patient Sequence Number: 1
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