MAUDE Adverse Event Report: ABBOTT VASCULAR FEMOSTOP GOLD; CLAMP, VASCULAR

Model Number	C11165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/18/2026
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.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The patient effect of hematoma is listed in instructions for use (ifu), as a potential adverse event associated with the use of the device.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that this was an arteriotomy closure of the right common femoral artery using a proglide device after a percutaneous coronary interventional procedure using a 7f sheath.Reportedly, the knot deployed in the tissue tract and not in the vessel.Manual compression was applied but hemostasis was not achieved.A femostop gold was used to achieve hemostasis which resulted in a hematoma and bruising at the access site.The size of the hematoma is unknown.There was no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• Brand Name: FEMOSTOP GOLD
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 25151290
• Report Number: 2024168-2026-01938
• Device Sequence Number: 9396665
• Product Code: DXC
• UDI-Device Identifier: 05414734050036
• UDI-Public: (01)05414734050036(17)270207(10)10907697
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K110193
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: C11165
• Device Catalogue Number: C11165
• Device Lot Number: 10907697
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Unknown
• Patient Weight: 86 KG