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

Model Number	12773-03
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
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 a prostyle device after an endovascular treatment procedure using an 8f sheath.Reportedly, after the plunger was depressed and withdrawn the suture was cut and the foot was retracted.The prostyle device was attempted to be removed; however, the device could not be removed.The prostyle device was able to be advanced slightly, the foot was repeatedly closed and opened, after which the device was able to be removed successfully.Under normal circumstances, the suture would engage the vessel wall and, once tied, achieve hemostasis; however, for an unknown reason, the suture did not capture the vessel wall and was instead pulled out without securing the tissue.Hemostasis was achieved with a non-abbott device.There were no reported adverse patient effects.No additional information was provided.
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 reported information, the investigation determined that the reported issues could not be determined.Factors that may contribute to suture malposition include but not limited to under insertion that the vessel was not properly captured during suture deployment or interaction with the patient anatomy or friable femoral vessel contributed to the reported difficulty.Factors that contribute to difficult to remove vessel, include, but not limited to, device interaction with patient anatomy, tissue or suture caught in foot.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: Perclose¿ ProStyle¿
• 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: 50794437
• Report Number: 2024168-2026-03583
• Device Sequence Number: 9442751
• Product Code: MGB
• UDI-Device Identifier: 08717648235184
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12773-03
• Device Catalogue Number: 12773-03
• Device Lot Number: 6040441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2026
• 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