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

Model Number	12773-03
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported this was an arteriotomy closure of the calcified right common femoral artery using the pre-close technique prior to a transcatheter aortic valve replacement (tavr) procedure.The sutures of two prostyle devices were successfully pre-placed.The sheath was upsized to greater than 10f and the tavr procedure was completed.Reportedly post procedure, one of the blue rail sutures broke when tightening down the suture over the wire using the snare knot pusher.Enough of the rail suture that broke was left to advance the knot successfully and achieve hemostasis with that same suture and the other successfully pre-placed suture.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 reported suture separation 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.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: 50876815
• Report Number: 2024168-2026-03684
• Device Sequence Number: 9223796
• Product Code: MGB
• UDI-Device Identifier: 08717648235184
• UDI-Public: (01)08717648235184(17)280430(10)6050643
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 6050643
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2026
• 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