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

Model Number	12773-03
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this was a venotomy closure of the right common femoral vein using the pre-close technique via an 8f sheath hole prior to a pulsed field ablation (pfa) procedure using volt.The suture of a prostyle device was successfully placed.The sheath was upsized to 14f and the pfa procedure was completed.Reportedly, during post close, the knot was advanced but there was still significant oozing at the access site; therefore, a second prostyle device was deployed.The lever was returned to its original position, and the footplate was retracted after the deployment; however, with the device not able to be removed from the access site, it was thought by the physician to have gotten hung up on a valve.The footplate did not retract fully back into device.The prostyle device was twisted, bent and pulled against resistance in a manner to try and release it from the inside of the vessel, resulting in a crack and separation where the metal meets the plastic at the elbow of the device.Once seen on angio, the operating room was immediately notified, and the patient was transferred for surgical cutdown.During the cutdown, the prostyle device was safely removed.Hemostais was achieved via surgical suturing.No additional structural damage was noted on the prostyle device.The patient was transferred to the intensive care unit icu) for 1 day and discharged without any further complications on (b)(6) 2026.There was a reported clinically significant delay in the procedure or therapy.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 - against resistance.

• 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: 50763312
• Report Number: 2024168-2026-03539
• Device Sequence Number: 9415116
• Product Code: MGB
• UDI-Device Identifier: 08717648235184
• UDI-Public: (01)08717648235184(17)280430(10)6051342
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 6051342
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/14/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown