ULTRAGUIDECTR
Report
- Report Number
- 3013479847-2024-00001
- Event Type
- Injury
- Date Received
- January 26, 2024
- Date of Event
- November 17, 2023
- Report Date
- January 26, 2024
- Manufacturer
- SONEX HEALTH
- Product Code
- LXH
- UDI-DI
- 00860002094700
- PMA / PMN Number
- K192873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016937 | ULTRAGUIDECTR | CARPAL TUNNEL RELEASE SYSTEM | LXH | SONEX HEALTH | 600112-001 | 00860002094700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |