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

Model Number	C11165
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
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 event is estimated as 09/11/2024, h6: medical device problem code 2017 - use after expiration.
Event or Problem Description
It was reported that two femostop gold devices had an error message (possibly related to the battery life).Additionally, the second device was used out of date [used after expiration].No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: there was no patient involvement.No additional information was provided.
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 investigation determined the noted battery issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.B3 correction: date of event updated from 9/11/2024 to 9/12/2024.H6 correction: code 2199 removed and 2645 added.

• 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: 20384114
• Report Number: 2024168-2024-11771
• Device Sequence Number: 20451334
• Product Code: DXC
• UDI-Device Identifier: 05414734050036
• UDI-Public: (01)05414734050036(17)230116(10)7986071
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/07/2024

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: 01/16/2023
• Device Model Number: C11165
• Device Catalogue Number: C11165
• Device Lot Number: 7986071
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2021
• 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