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

Model Number	12673-03
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was an arteriotomy closure of the calcified right common femoral artery using the pre-close technique via an 8f sheath hole prior to an endovascular aneurysm repair (evar) procedure.Reportedly, with 4 proglide devices, the footplates would not close.After removal of the devices, the sheath was upsized to a16f, and the evar procedure was completed.Hemostasis was achieved via cutdown.There were no reported adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported difficulty closing the foot was not confirmed during functional testing.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 issue appears to be related to circumstances of the procedure.In this case, it is likely that challenging anatomical conditions (tissue caught in the foot) led to the reported failure to close the foot.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.The additional devices referenced in b5 are filed under separate medwatch report numbers.

• 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: 50859321
• Report Number: 2024168-2026-03657
• Device Sequence Number: 9508758
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 6061041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2026
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 230 LB
• Patient Race: White