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

Model Number	12773-03
Medical Device Problem Codes	Failure to Cycle (1142); Unintended System Motion (1430); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was venous closure of the right common femoral vein using a prostyle device using the pre-close technique via a 10f sheath hole prior to an ablation interventional procedure.Reportedly, during step 2, the plunger was pulled back/dislodged (protruding) but still in the device.The plunger was then pushed back into the handle/device.The plunger was then depressed, and a cuff miss was noted when the plunger was removed (step3).The suture of one new prostyle device was successfully pre-placed.The sheath was upsized to a 13f, and the ablation procedure was completed.Hemostasis was achieved with the pre-placed prostyle suture.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.H6: medical device problem code: 2017 - use after damage.

• 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: 50869951
• Report Number: 2024168-2026-03665
• Device Sequence Number: 10715164
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 6052741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2026
• 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