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

Model Number	12673-03
Medical Device Problem Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
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.It was reported the guide wire was not removed prior to deployment.It should be noted that the perclose proglide instructions for use (ifu) states, ¿advance the device over the guide wire until the guide wire exit port is just above the skin line.Remove the guide wire before the guide wire exit port crosses the skin line.Based on the information received, the investigation determined that the reported issue appears to be related to user error.In this case, it appears the device was deployed with the guide wire in place causing the sutures to become entangled with the device inducing the entrapment.The malposition may have also been induced due to guide wire in place during deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that this was an arteriotomy closure of a left common femoral artery using a proglide device in a percutaneous coronary intervention procedure with a small-bore sheath.Reportedly, the knot was deployed over the wire and entrapped the wire during the process.The suture and device also became tangled.The knot was located above the skin; therefore, the physician was advised to cut and remove the suture.Once the suture was removed, the device was freed and was removed safely under guidance.Wire access was maintained, and another perclose device was used to achieve hemostasis.There were no reported adverse patient effects.No additional information was provided.

• Brand Name: PERCLOSE PROGLIDE¿
• 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 25555381
• Report Number: 2024168-2026-02458
• Device Sequence Number: 17431449
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• UDI-Public: (01)08717648013089(17)271130(10)6010841
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 6010841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown