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

Model Number	401763
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a transcatheter aortic valve implantation (tavi) procedure, vein access gained with a 6fr, and the electrode was inserted and balloon inflated.The electrode became stuck in a vein branch in the pelvis.The balloon was deflated; electrode was removed.Upon removal, the physician observed that the distal tip of the catheter had detached and was left in the vein branch.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 5f pacel (flow direct) pacing catheter was received for analysis.A 1.25 cc limited volume syringe was also noted to be returned.The distal tip electrode was noted to be fractured and detached from the catheter shaft.The fractured and detached tip electrode was not returned with the device.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ABBOTT MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ABBOTT MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23379560
• Report Number: 2182269-2025-00135
• Device Sequence Number: 8871878
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: (01)05414734007856(10)10810453(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 05/15/2026

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: 09/30/2026
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 10810453
• 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: 09/28/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown