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

Model Number	401763
Medical Device Problem Codes	Leak/Splash (1354); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation the physician checked the pacel bipolar pacing catheter and it worked.The catheter was then pushed through the contamination sleeve (first the colorless side and then through the green side).Since the green opening of the sleeve is very small it damaged the balloon and caused it to leak when inflated.A new pacel was used to continue the procedure.There were no adverse patient effects.No additional information was provided.Subsequent to the initially filed report, the following information was received: it was reported that during preparation the physician inflated the pacel bipolar pacing catheter balloon outside the patient and it worked without issue.The catheter was then pushed through the contamination sleeve which is attached to the introducer sheath inserted in the patient.Since the green opening of the sleeve is very small, resistance was felt and the physician removed the catheter from the sleeve.Upon inspection, the balloon of the catheter was noted to be damaged causing the balloon to leak.A new pacel was used to continue the procedure.There were no adverse patient effects.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported balloon damage was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot-specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported balloon damage appears to be related to circumstances of the procedure.The catheter was returned with the balloon separated from the shaft and not returned.The damage is likely related to the resistance felt when inserting the catheter into the contamination sleeve as stated in the reported details.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Updated: b5, b7, d9, e3, g3, g6, h2, h3, h6 (codes 4755, 4118, 3233, 11 no longer apply).

• 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: 50459914
• Report Number: 2024168-2026-03324
• Device Sequence Number: 18685956
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: (01)05414734007856(17)270430(10)11140016
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 11140016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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