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

Model Number	C11165
Medical Device Problem Codes	Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the femostop was applied, the pressure gauge does not work and the dome cannot inflate.Therefore, the femostop was replaced.The device was used past the expiration date.There was no reported adverse patient effects and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code: 2017 - use after expiration.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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.Review of the lot history record indicated the device was used after expiration.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information provided, a definitive cause for the reported inflation issue could not be determined.Factors that may contribute to an inflation issue include, but are not limited to, manufacturing, too little adhesive between arch and dome, dome has not bottomed out in the flat base section of the arch, adhesive sets before dome applied or user technique.Review of the lot history record indicated an expiration date (use by date) of 17-novemeber-2024 and the procedure date was (b)(6) 2025 which is post expiration.Instructions for use provides labelling symbology explanation for use date.In this case, it is unknown if use of the device after expiration would have contributed to the reported event.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: FEMOSTOP¿
• 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: 21734160
• Report Number: 2024168-2025-03289
• Device Sequence Number: 9002197
• Product Code: DXC
• UDI-Device Identifier: 05414734050036
• UDI-Public: (01)05414734050036(17)241107(10)9001606
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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 Expiration Date: 11/07/2024
• Device Model Number: C11165
• Device Catalogue Number: C11165
• Device Lot Number: 9001606
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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