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	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had right-hand and left-hand carpal tunnel release using ultraguidectr with ultrasound guidance.11 days after surgery, patient had onset of increasing pain, stiffness and swelling with clear fluid discharge from right hand incision site only.Patient states the left hand is healing well without issues.The patient presented to emergency department for evaluation concerning flexor tenosynovitis/infectious complication of right hand.No fever or chills.The patient had superficial abrasion to right wrist 3-4 days prior by moving wood.Patient reported that right hand was healing well but woke up with the new symptoms: acute onset of significant pain to right wrist and palmar aspect of right hand along fourth or fifth flexor sheath.The possibility that the infectious complication resulted from firewood abrasion was noted.Open and debridement of right hand.Antibiotics were given.Diagnosis was infectious flexor tenosynovitis.No device malfunction was reported.
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.

• 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: 17998348
• Report Number: 3013479847-2023-00008
• Device Sequence Number: 15142049
• 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: 65 YR
• Patient Sex: Male