MAUDE Adverse Event Report: ABBOTT VASCULAR Perclose ProGlide¿; DEVICE, HEMOSTASIS, VASCULAR

Model Number	12673-03
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: unable to advance proglide in or out of right femoral artery.Patient brought to the operating room.Patient was here for heart cath - unable to do heart cath through the radial artery due to tortuosity so we switched to femoral approach.Unable to determine the reason why this happened.From operative report: at the end of the procedure, perclose proglide device was used to close the arteriotomy.During device deployment, device foot plate was stuck in the subcutaneous tissue and was unable to be retrieved with manual traction.Manual pressure was immediately held over the right groin and vascular surgery assessed the patient and recommended taking patient to the operating room emergently for surgical cutdown, device retrieval and closure of arteriotomy.

• Brand Name: Perclose ProGlide¿
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 50913336
• Report Number: 50913336
• Device Sequence Number: 17593486
• Product Code: MGB
• UDI-Device Identifier: 28717648013083
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026
• Report Date (Section F): 09/03/2026

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: 6061041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 265 LB
• Date Report Sent to FDA: 09/03/2026