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

Model Number	401763
Medical Device Problem Codes	Material Rupture (1546); Communication or Transmission Problem (2896); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the patient was placed in the supine position.The right femoral vein was selected as the puncture site.After skin disinfection and sterile draping, local infiltration anesthesia was administered with 1% lidocaine.A puncture needle was inserted approximately 1 cm below the right inguinal groove, and access to the femoral vein was successfully achieved.A guidewire was advanced smoothly, a 6f sheath was inserted, and the guidewire was withdrawn.A pacel pacing catheter was then introduced for temporary transvenous right ventricular pacing.After the electrode was advanced to 30 cm, 1 ml of air was injected to inflate the balloon.Despite repeated adjustments of the electrode position, the pacing catheter was not pacing, and the electrode could not be smoothly advanced into the right ventricle.After deflation and withdrawal of the catheter, balloon rupture was noted.The pacing catheter was replaced, and after repeated adjustments, the electrode was successfully advanced into the right ventricle to a depth of 80 cm.The pacing rate was set at 60 beats per minute, pacing output at 2.5 v, and sensitivity at 5 mv.Electrocardiogram (ecg) monitoring showed a paced rhythm, with right ventricular apical pacing at a rate of 60 beats per minute.The puncture site was compressed and bandaged, and the right lower limb was immobilized.After an hour, the procedure was completed successfully.The patient was stable with no adverse effects.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ABBOTT MEDICAL; 3200 lakeside drive; santa clara CA 95054
• Manufacturer (Section G): ABBOTT MEDICAL; 3200 lakeside drive; santa clara CA 95054
• Manufacturer Contact: lindsey bell ; 3200 lakeside drive; santa clara, CA 95054 ; 9519143996
• MDR Report Key: 25115730
• Report Number: 3004742232-2026-00106
• Device Sequence Number: 21400713
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: (01)05414734007856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152784
• 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,Followup
• Report Date (Section B): 06/02/2026

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: 10971030
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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