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

Catalog Number UNK FEMOSTOP GOLD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Nervous System Injury (2689)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

B3: date of event is estimated.D4: the udi is unknown due to the part/lot number was not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that during a training session, a femostop device was placed on a trainee on the right groin and inflated to 120 mmhg for 60-90 seconds before it was deflated.The process was repeated three additional times.When the trainee stood up following the device being used, the trainee felt a strange sensation and the right leg felt tight.Later that evening the trainee felt further altered sensation to the right leg, arm, and face.The main injuries/symptoms suffered include a pinched/compressed nerve causing pain, altered sensation and discomfort to his groin, leg, arm, and face, along with psychological symptoms.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: the trainee was off work and required care and assistance.No additional information was provided.

Manufacturer Narrative

The incident information was reviewed; however, there was no reported device malfunction.A review of the lot history record and complaint history could not be conducted because the part and lot number were not provided.The patient effects of nerve damage, nervous system damage, and injury/impairment are listed in the femostop gold instructions for use (ifu), as potential adverse events of use of the device.Pain is a general effect that may be associated with the procedure, the primary disease, or preexisting conditions and does not reflect a specific issue.Based on the case information, 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.D1: brand name d4: catalog # e1: reporter name, title, facility name, street address, postal code.E3: occupation.

• Brand Name: FEMOSTOP GOLD
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17452455
• MDR Text Key: 320370483
• Report Number: 2024168-2023-08418
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FEMOSTOP GOLD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male