MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Perclose¿ ProStyle¿; Device, hemostasis, vascular

Model Number	12773-03
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Perclose suture was not attached to needle and could not be deployed.This happened with two separate perclose devices.Replaced with a third perclose device that was deployed.

• Brand Name: Perclose¿ ProStyle¿
• Common Device Name: Device, hemostasis, vascular
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 50818050
• Report Number: 50818050
• Device Sequence Number: 10677640
• Product Code: MGB
• UDI-Device Identifier: 08717648235184
• UDI-Public: (01)08717648235184
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/09/2026
• Report Date (Section F): 09/09/2026

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: 6042943
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 157 LB
• Date Report Sent to FDA: 09/09/2026