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

Model Number	401761
Medical Device Problem Codes	Inflation Problem (1310); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the balloon was properly deflated, but during removal, it was found that the balloon was cracked.The procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11 one 5f pacel (flow direct) pacing catheter and one 1.25cc limited volume syringe were received for analysis.The balloon was noted to be torn and rolled up from the distal end of the balloon.No other visual anomalies were noted.The limited volume syringe was removed from the device, the plunger was retracted to the 1.25cc line then the returned syringe was reattached to the stopcock before testing.The entire catheter submersed in a water bath at 37º celsius for two minutes.The syringe plunger was then depressed; the balloon did not inflate.The syringe was then removed and pulled back and reattached to the catheter again, the catheter was then submersed in water.The syringe plunger was then depressed a second time and the balloon did not inflate.Microscopic inspection confirmed a tear at the distal end of the balloon.The balloon adhesive appeared intact.The results of the investigation confirmed a tear at the distal end of the balloon.The balloon was unable to inflate due to a leak at the tear location.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the inflation issue and tear 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
• 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: 22014605
• Report Number: 2182269-2025-00024
• Device Sequence Number: 12735766
• Product Code: LDF
• UDI-Device Identifier: 05414734021906
• UDI-Public: (01)05414734021906(10)10420387(17)251231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 12/31/2025
• Device Model Number: 401761
• Device Catalogue Number: 401761
• Device Lot Number: 10420387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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