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

Model Number 401762

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.

• 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
• 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 Key: 8728639
• MDR Text Key: 149004285
• Report Number: 2182269-2019-00083
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734001045
• UDI-Public: 05414734001045
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K914185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 401762
• Device Catalogue Number: 401762
• Device Lot Number: 6808401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2019
• 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): Other