MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Perclose ProGlide¿; Device, Hemostasis, Vascular

Model Number	12673-03
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was an arteriotomy closure of the right common femoral artery using a proglide device using the pre-close technique via an 18f sheath hole prior to a fenestrated abdominal aortic aneurysm (aaa) repair interventional procedure.The first device was deployed and pre-placed as intended.Reportedly, during use of the second device after deployment, during step 4, the footplate would not retract and was stuck.The lever was stuck and could not be returned to the original position/lowered.A cut-down was performed to remove the device and a guide break held together by the actuator wire was noted.All broken sections of the device were removed.During the cut-down, when the device was removed, it had the first replaced suture stuck on the device along with the second suture.No vessel damage was noted, and no additional devices were used.The sheath size remained an 18f, and the aaa procedure was completed.Hemostasis was achieved with manual compression.There was no reported adverse patient effect.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.The additional device referenced in b5 is filed under a separate medwatch report number.

• Brand Name: Perclose ProGlide¿
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50614462
• Report Number: 2024168-2026-03450
• Device Sequence Number: 16108489
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• UDI-Public: (01)08717648013089(17)270430(10)5063041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 5063041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Vessel Closure: ProGlide.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown