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

Model Number	C11165
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "strap" [belt] was missing when opening a femostop gold.Additionally, based on the lot number, the device was used after expiration.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of procedure estimated as (b)(6) 2024 h6: medical device problem code 2017 clarifier- use after expiration.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.Missing belt may be attributed to several factors including, but not limited to, manufacturing/packaging of the device, transport of the device, handling at the account, inadvertent mishandling during unpackaging, preparation or during the procedure.A conclusive cause for the reported event could not be determined; however, the treatment appears to be related to circumstances of the procedure.Review of the lot history record indicated an expiration date (use by date) of 06-may-2024 and the procedure date was (b)(6) 2024 which is post expiration.It should be noted in the label, graphical symbols for medical device labeling section, it indicates use-by date symbol, which is next to the expiration date.In this case, use of the device after expiration would not have contributed to the reported event.Based on the reported information and 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: FEMOSTOP GOLD
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19734162
• Report Number: 2024168-2024-08287
• Device Sequence Number: 20598595
• Product Code: DXC
• UDI-Device Identifier: 05414734050036
• UDI-Public: (01)05414734050036(17)240506(10)8548081
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: 05/06/2024
• Device Model Number: C11165
• Device Catalogue Number: C11165
• Device Lot Number: 8548081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2022
• 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