MAUDE Adverse Event Report: AVALIGN DELIVERY SYSTEMS DIVISION UCH SMBN 5MM X 120MM SKELETAL MUSC BIOP NDLM; ACCESSORIES, ARTHROSCOPIC

Model Number 72-238068

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problems Itching Sensation (1943); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Numbness (2415)

Event Date 12/08/2021

Event Type  Injury  

Event Description

Once the needle muscle biopsy was trocar inside the patient thigh, the needle trocar was not sliding properly on the first pass as it was stiff to slide up and down.On the second pass inside the patient thigh, the trocar was even stiffer than it was on the first pass, making it almost impossible to slide up and down.It was basically stuck in the patient thigh and would not come out despite gentle attempts to pull back on it.This led me, in discussion with the patient who agreed verbally to my approach, to pull harder in one attempt on the trocar which i did and i was successful in removing the trocar that way.The patient reported intense pain at the time which subsided after a few minutes.I instructed the team that we do not use this device any further on patients until we can verify it does not malfunction anymore.As a result of this malfunction, the patient suffered permanent injury to one of the sensory nerves to the thigh (the lateral femoral cutaneous nerve).I evaluated the patient on december 10 and december 15 and have remained since then in contact with the patient.The biopsy site continues to feel like it is burning when touched, numb, and itchy.Nothing has helped it.She did not want to take any medication for it.Fda safety report id # (b)(4).

• Brand Name: UCH SMBN 5MM X 120MM SKELETAL MUSC BIOP NDLM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): AVALIGN DELIVERY SYSTEMS DIVISION
• MDR Report Key: 13479763
• MDR Text Key: 285414244
• Report Number: MW5107270
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 72-238068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White