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

Model Number	12673-03
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
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: failure to follow steps / instructions the additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that this was an venous closure of the right common femoral vein using a proglide device using the pre-close technique via a 6f sheath hole prior to a atrial septal defect (asd) interventional procedure.Reportedly, the device was deployed properly but the knot and the suture loop was visible outside of the tissue tract, and the knot locked prematurely, therefore, the physician was unable to advance the knot and removed the device.The knot was formed and intact.The suture of one new proglide device was successfully pre-placed.The sheath was upsized to a 14f and the asd procedure was completed.Hemostasis was achieved with the pre-placed proglide suture and a figure of 8 stitch.There was no reported adverse patient effect.During return device analysis, it was noted that the returned suture was removed from the guide tube for further inspection and was also pulled from the suture bearing with no anomalies noted.It appears two sutures were returned in the loops.Both sutures were cut approximately 10 inches from the knot and were not scratched nor torn.The total length of both sutures was approximately 19 inches in length.An additional complaint (cn-370534) was created to capture the second suture that was returned looped and tangled with the initial reported device suture.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: 25285245
• Report Number: 2024168-2026-02137
• Device Sequence Number: 15967717
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• UDI-Public: (01)08717648013089(17)280131(10)6031141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 6031141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2026
• 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: VESSEL CLOSURE: PROGLIDE
• Patient Sex: Male