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

Model Number	12673-03
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was closure of an unspecified access site using a proglide device using the pre-close technique prior to a endovascular leak repair interventional procedure.Reportedly, a cuff miss "[suture retrieval issue]" occurred with three proglide devices.The sutures of two new proglide devices were successfully pre-placed.The endovascular leak repair procedure was completed.Post procedure during knot advancement, one of the pre-placed sutures snapped/separated.It is unknown which of the two pre-placed sutures snapped.The remaining suture/knot was advanced to the vessel and tightened as intended.Manual compression was applied to achieve hemostasis.There was no reported adverse patient effect.No additional information was provided.
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.Based on the information provided, a definitive cause for the reported suture separation during knot advancement could not be determined.In this case, it is possible that the tensioning of the suture was not coaxial during knot advancement and contributed to the reported suture separation.However, this cannot be conclusively determined.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 ProGlide¿
• 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: 50935351
• Report Number: 2024168-2026-03747
• Device Sequence Number: 13443118
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/29/2026

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: 6022541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2026
• 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
• Patient Sex: Unknown