MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Pacel¿; Electrode, Pacemaker, Temporary

Model Number	401763
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was diagnosed with third-degree atrioventricular (av) block and had an unstable cardiac rhythm, meeting the clinical indications for temporary cardiac pacing.A bedside sterile temporary pacemaker implantation procedure was planned.The cardiologist strictly followed aseptic technique.After removing the pacel bipolar pacing catheter from the package, the original syringe provided in the kit was used to properly withdraw air and slowly inject the standard volume of 1 ml of air into the balloon at the distal tip of the lead.Immediately after inflation, it was observed that the balloon at the distal tip of the pacing lead had ruptured.The incident occurred during the pre-use, extracorporeal balloon inflation test with the pacel in contact with the patient¿s blood path during the balloon rupture.There are no indications as to what caused the balloon to burst.A new pacel bipolar pacing catheter of the same model and batch was used to successfully complete the procedure.The patient remained hemodynamically stable, with no adverse reactions.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• Brand Name: Pacel¿
• Common Device Name: Electrode, Pacemaker, Temporary
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): Abbott Medical Reg# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50821961
• Report Number: 2024168-2026-03617
• Device Sequence Number: 18819662
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: (01)05414734007856(17)270630(10)11224987
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K914185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 11224987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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