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

Model Number	401770
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pacel bipolar pacing catheter was implanted due to atrial fibrillation with a slow ventricular rate (bradycardia).There was no vessel preparation and no other devices were involved.Intraoperative testing demonstrated satisfactory pacing parameters.The catheter was secured with pressure dressing, and the patient was transferred back to the ward.On postoperative day 1, 2.5 hours following pacel electrode extraction, the patient developed hypotension.The patient¿s base rate was 130/90.Bedside ultrasound examination confirmed the presence of pericardial effusion without obvious perforation.Pericardiocentesis and drainage were performed promptly.Following the procedure, the patient's blood pressure increased, and repeat ultrasound confirmed that the pericardial effusion was no longer increasing.A drainage catheter was left in place, and the patient was admitted to the intensive care unit (icu) for observation.On postoperative day 2, the patient's vital signs remained stable with no significant changes compared to the previous day.On (b)(6) 2026, the patient remains under observation in the icu due to a small amount of fluid that has continued to leak from the previously treated pericardial effusion.In the opinion of the physician, the cause of the patient¿s hypotension was the tip of the pacel being too stiff and the pericardial effusion was likely caused by electrode placement adjacent to the free wall.Pericardial effusion may easily occur during electrode removal, and this condition is unrelated to the pacel itself.No additional information was provided.
Event or Problem Description
It was reported that a pacel bipolar pacing catheter was implanted due to atrial fibrillation with a slow ventricular rate (bradycardia).There was no vessel preparation and no other devices were involved.Intraoperative testing demonstrated satisfactory pacing parameters.The catheter was secured with pressure dressing, and the patient was transferred back to the ward.On postoperative day 1, 2.5 hours following pacel electrode extraction, the patient developed hypotension.The patient¿s base rate was 130/90.Bedside ultrasound examination confirmed the presence of pericardial effusion without obvious perforation.Pericardiocentesis and drainage were performed promptly.Following the procedure, the patient's blood pressure increased, and repeat ultrasound confirmed that the pericardial effusion was no longer increasing.A drainage catheter was left in place, and the patient was admitted to the intensive care unit (icu) for observation.On postoperative day 2, the patient's vital signs remained stable with no significant changes compared to the previous day.On (b)(6) 2026, the patient remains under observation in the icu due to a small amount of fluid that has continued to leak from the previously treated pericardial effusion.In the opinion of the physician, the cause of the patient¿s hypotension was the tip of the pacel being too stiff and the pericardial effusion was likely caused by electrode placement adjacent to the free wall.Pericardial effusion may easily occur during electrode removal, and this condition is unrelated to the pacel itself.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Correction: g1 manufacturing site and address.

• 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; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50223215
• Report Number: 2024168-2026-03152
• Device Sequence Number: 10274240
• Product Code: LDF
• UDI-Device Identifier: 05414734001113
• UDI-Public: (01)05414734001113(17)281130(10)11188443
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K875059
• 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,Followup
• Report Date (Section B): 09/23/2026

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 Model Number: 401770
• Device Catalogue Number: 401770
• Device Lot Number: 11188443
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 08/26/2026; 09/18/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/18/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown