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

Model Number	401762
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 8728639
• Report Number: 2182269-2019-00083
• Device Sequence Number: 1807921
• Product Code: LDF
• UDI-Device Identifier: 05414734001045
• UDI-Public: 05414734001045
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K914185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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