MAUDE Adverse Event Report: ABBOTT VASCULAR INC. PERCLOSE PROGLIDE¿; DEVICE, HEMOSTASIS, VASCULAR

Model Number	12673-03
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported issue appears to be related to operational context.In this case, it is likely that interaction with the calcified patient anatomy or friable femoral vessel contributed to the reported difficulty.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 device referenced in b5 is being filed under a separate medwatch report.
Event or Problem Description
It was reported this was a venotomy closure of a right common femoral vein using the pre-close technique via a 7f sheath hole prior to a diagnostic procedure.Reportedly, one proglide suture was successfully pre-placed.The sheath was upsized to 12f and the procedure was completed.However, when performing suture management, it was observed suture had only captured one side of vessel wall and didn't close.An additional proglide was inserted and deployed, but the same issue occurred.An additional closure device was used to achieve hemostasis.There were no adverse patient effects and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• Brand Name: PERCLOSE PROGLIDE¿
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 25219491
• Report Number: 2024168-2026-02046
• Device Sequence Number: 10073896
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• UDI-Public: (01)08717648013089(17)280131(10)6031141
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P960043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/19/2026

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: 6031141
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• 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 Sex: Unknown