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

Model Number	401764
Medical Device Problem Codes	Inflation Problem (1310); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 5f pacel (flow directed) pacing catheter was received for evaluation.The 1.25cc volume limited syringe was also returned.The reported event of a ruptured balloon was confirmed.The balloon was noted to be torn and ruptured where the adhesive seal meets the balloon at the proximal end of the balloon.The proximal and distal adhesive bonds for the balloon remained intact.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn and ruptured balloon remains unknown.
Event or Problem Description
During the paroxysmal supraventricular tachycardia procedure, a pacing catheter was inserted into the patient and blood returned to the syringe.The catheter was removed, and the tip of the balloon was found to be ruptured.The catheter was exchanged, and the procedure was completed with no adverse consequences to the patient.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21969955
• Report Number: 2182269-2025-00022
• Device Sequence Number: 8350899
• Product Code: LDF
• UDI-Device Identifier: 05414734022521
• UDI-Public: (01)05414734022521(10)10394001(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 401764
• Device Catalogue Number: 401764
• Device Lot Number: 10394001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown