MAUDE Adverse Event Report: SONEX HEALTH ULTRAGUIDECTR; CARPAL TUNNEL RELEASE SYSTEM

Model Number	600112-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Seroma (2069)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Additionally, the lot number was not reported and therefore a review of device history records could not be performed.Infection is referenced in the ultraguidectr instructions for use as a possible complication.No device malfunction was reported.
Event or Problem Description
The patient had right hand carpal tunnel release using ultraguidectr with ultrasound guidance.18 days later the patient went to the emergency department with right hand wrist pain, a right wrist seroma at site of incision, and pain with extension of small finger.Irrigation and drainage were performed at bedside.Serratia marcescens was noted, which is not particularly common organism for infection and is often considered an opportunistic infection (i.E., affects people with increased susceptibility to infection).Patient was admitted for iv antibiotics, and their chronic lymphocytic leukemia (cll) medication were held.Symptoms improved but did not completely resolve.Two days later the patient was taken to the operating room to open the flexor tendon sheaths of the small and index fingers.Diagnosis was infectious flexor tenosynovitis.No device malfunction was reported.

• Brand Name: ULTRAGUIDECTR
• Common Device Name: CARPAL TUNNEL RELEASE SYSTEM
• Manufacturer (Section D): SONEX HEALTH; 950 blue gentian road #200; eagan 55121
• Manufacturer (Section G): SONEX HEALTH; 950 blue gentian road #200; eagan 55121
• Manufacturer Contact: sara petrie ; 950 blue gentian road #200; eagan 55121
• MDR Report Key: 17998320
• Report Number: 3013479847-2023-00007
• Device Sequence Number: 15123575
• Product Code: LXH
• UDI-Device Identifier: 00860002094700
• UDI-Public: (01)00860002094700(17)UNKNOWN(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K192873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 600112-001
• 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: 09/26/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male