MAUDE Adverse Event Report: ABBOTT VASCULAR INC. PERCLOSE¿ PROSTYLE¿; DEVICE, HEMOSTASIS, VASCULAR

Model Number	12773-02
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional perclose prostyle devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that this was an arteriotomy closure of the right common femoral artery (rcfa) using the pre-close technique via prior to a thoracic endovascular aneurysm repair (tevar) interventional procedure.The sutures of the first prostyle device was successfully pre-placed.Reportedly, a cuff miss [suture retrieval issue] occurred with six prostyle devices in a row.The tevar procedure was abandoned at the rcfa.Hemostasis was achieved with the pre-placed prostyle suture in the rcfa.The sutures of two new prostyle devices were successfully pre-placed without issue contralaterally.The sheath was upsized to a large bore sheath and the tevar procedure was continued contralaterally.Hemostasis was achieved with the preplaced prostyle sutures on the contralateral access site.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
Visual inspections were performed on the returned device.The reported needle to cuff miss was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.The reported difficulties and subsequent treatment appear to be related to an interaction of the device with patient anatomy or inability to maintain position/stability of the device during deployment due to circumstances of the procedure.Based on the results of the complaint investigation 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 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20623795
• Report Number: 2024168-2024-13053
• Device Sequence Number: 8168610
• Product Code: MGB
• UDI-Device Identifier: 08717648344039
• UDI-Public: (01)08717648344039(17)260531(10)4061242
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 12773-02
• Device Catalogue Number: 12773-02
• Device Lot Number: 4061242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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: VESSEL CLOSURE: PROSTYLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown