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

Model Number 600112-001

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

Patient Problems Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)

Event Date 11/17/2023

Event Type  Injury  

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.Tendon injury is referenced in the ultraguidectr instructions for use as a possible complication.No device malfunction was reported.

Event Description

The ultraguidectr primed and functioned normally during the procedure on (b)(6) 2023, and the procedure was uneventful.The physician indicated that he took multiple passes with the device to ensure a complete release, but did not note any unusual difficulty cutting the ligament.The patient tolerated the procedure well and the post-operative course was uneventful until 3 weeks post-procedure, when the patient heard a pop in their hand and was having difficulty normally bending the ring finger.An evaluation with diagnostic ultrasound confirmed a flexor digitorum superficialis (fds)-ring finger rupture at the level of the wrist crease.The physician explored and repaired the tendon, and the patient is recovering uneventfully.The physician did not see anything unusual at the time of the tendon repair and the patient had no other identifiable risk factors for tendon rupture.

• Brand Name: ULTRAGUIDECTR
• Type of Device: CARPAL TUNNEL RELEASE SYSTEM
• Manufacturer (Section D): SONEX HEALTH; 950 blue gentian road #200; eagan MN 55121
• Manufacturer (Section G): SONEX HEALTH; 950 blue gentian road #200; eagan 55121
• Manufacturer Contact: sara petrie ; 950 blue gentian road #200; eagan, MN 55121
• MDR Report Key: 18588050
• MDR Text Key: 333850427
• Report Number: 3013479847-2024-00001
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00860002094700
• UDI-Public: (01)00860002094700(17)UNKNOWN(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 600112-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention