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

Model Number	12773-03
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that suture placement in the right common femoral artery using a prostyle device using the pre-close technique via a 6f sheath hole prior to a transcatheter aortic valve replacement (tavr) interventional procedure.The sutures of two prostyle devices were successfully placed.The sheath was upsized to a 16f sheath, and the tavr procedure was completed.Reportedly post procedure, during knot advancement of the second device suture, a frayed suture was noted.The suture break ultimately occurred after the frayed suture while tightening the knot.The first pre-placed suture worked as intended and achieved hemostasis.There was no reported adverse patient effect.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 reported suture separation and frayed suture could not be determined.Factors that may contribute to suture separation during knot advancement include, but are not limited to, user technique (tensioning angle not coaxial) or suture/ nick damage.Factors that may contribute to frayed suture include, but are not limited to, an interaction of the device with patient anatomy where the suture got pushed over the posterior side of the guide tube edge as it tract during deployment or suture snag during harvest.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: 50869249
• Report Number: 2024168-2026-03662
• Device Sequence Number: 10674003
• Product Code: MGB
• UDI-Device Identifier: 08717648235184
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/23/2026

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: 6051343
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Closure Device: ProStyle
• Patient Sex: Unknown