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

Model Number	12673-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
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.The reported patient effect of hemorrhage/blood loss/bleeding is listed in the perclose proglide instructions for use as a known patient effect of use with suture mediated closure device procedures.Based on the case information, there was no conclusive cause for the reported difficulty, and the relationship to the product, if any that can be determined.There is therefore, no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
Event or Problem Description
It was reported this was an arteriotomy closure of a left common femoral artery using a proglide device after a percutaneous transluminal angioplasty (pta) procedure with a 7f sheath.Reportedly, a proglide device was deployed, but bleeding still occurred.Therefore, a starclose device was inserted and successfully deployed.However, bleeding still remained.Manual compression was then used to achieve hemostasis.There were no adverse patient effects and no reported clinically significant delay in the procedure or therapy.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: 25246813
• Report Number: 2024168-2026-02108
• Device Sequence Number: 21439723
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• UDI-Public: (01)08717648013089(17)270331(10)5050941
• 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): 05/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 5050941
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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