VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
Report
- Report Number
- 1319211-2024-00005
- Event Type
- Malfunction
- Date Received
- February 1, 2024
- Date of Event
- January 2, 2024
- Report Date
- February 28, 2024
- Manufacturer
- ANGIODYNAMICS
- Product Code
- GEX
- UDI-DI
- H787114031015
- PMA / PMN Number
- K171921
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4)
THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF" THE FIBER BROKE WHEN ATTACHED TO LASER GENERATOR" WAS NOT CONFIRMED DUE TO THE FIBER NOT BEING RETURNED FOR EVALUATION. WITHOUT RECEIVING A COMPLAINT SAMPLE FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. DURING THE PACKAGING STEP, THE FIBERS ARE INSPECTED FOR DAMAGE. A POTENTIAL ROOT CAUSE IS HANDLING DAMAGE AFTER LEAVING ANGIODYNAMICS FACILITY. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS; I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: THE DIRECTIONS FOR USE (16900430-01) WHICH IS SUPPLIED TO THE END USER WITH THE REPORTED CATALOG NUMBER CONTAINS THE FOLLOWING STATEMENT: WARNING CONTENTS SUPPLIED STERILE USING AN ETHYLENE OXIDE (EO) PROCESS. DO NOT USE IF STERILE BARRIER IS DAMAGED. IF DAMAGE IS FOUND, CALL YOUR SALES REPRESENTATIVE. INSPECT PRIOR TO USE TO VERIFY THAT NO DAMAGE HAS OCCURRED DURING SHIPPING. INTENDED USE THE ANGIODYNAMICS*, INC. VENACURE EVLT NEVERTOUCH DIRECT* PROCEDURE KITS ARE INDICATED FOR ENDOVASCULAR COAGULATION OF THE GREAT SAPHENOUS VEIN (GSV) IN PATIENTS WITH SUPERFICIAL VEIN REFLUX, FOR THE TREATMENT OF VARICOSE VEINS AND VARICOSITIES ASSOCIATED WITH SUPERFICIAL REFLUX OF THE GREAT SAPHENOUS VEIN (GSV), AND FOR THE TREATMENT OF INCOMPETENCE AND REFLUX OF SUPERFICIAL VEINS OF THE LOWER EXTREMITY PRECAUTION: - PRIOR TO AND DURING USE, AVOID DAMAGING THE FIBER BY STRIKING, STRESSING, OR EXCESSIVE BENDING. DO NOT COIL THE FIBER TIGHTER THAN A DIAMETER OF 16CM. CLINICAL SAFETY AND EFFECTIVENESS DATA IS NOT AVAILABLE FOR OTHER FIBER TIP DESIGNS AND DIAMETERS. FIBER REMOVAL FROM DIE CARD: NOTE: ORIENT THE DIE CARD SUCH THAT THE ANGIODYNAMICS LOGO IS LEGIBLE. 1. USE ASEPTIC TECHNIQUE TO REMOVE ALL COMPONENTS FROM POUCHES. A. TO REMOVE FIBER TIP END FIRST: 2A. ADVANCE THE FIBER TIP INTO THE SHIP TUBE SLIGHTLY TO FACILITATE REMOVAL FROM DIE CARD TAB. 3A. UNCLIP THE FIBER FROM THE BOTTOM RIGHT INSIDE TAB OF THE CARD. 4A. PULL THE FIBER TIP OUT OF THE SHIP TUBE. 5A. UNCOIL THE FIBER IN A COUNTERCLOCKWISE MANNER, PULLING THE FIBER VERTICALLY FROM THE CARD. 6A. UNCLIP THE SMA FROM THE RAISED TABS. B. TO REMOVE FIBER SMA END FIRST: 2B. UNCLIP THE SMA FROM THE RAISED TABS OF THE CARD. 3B. UNCOIL THE FIBER IN A CLOCKWISE MANNER, PULLING VERTICALLY FROM THE CARD. 4B. PULL THE FIBER TIP FROM THE SHIP TUBE. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).
A NURSE REPORTED AN ISSUE WITH A NEVERTOUCH DIRECT FIBER . IT WAS REPORTED THAT THE FIBER "BROKE" WHEN ATTACHED TO LASER GENERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414867 | VENACURE NEVERTOUCH DIRECT PROCEDURE KIT | VENACURE ENDOVENOUS LASER TREATMENT FIBER | GEX | ANGIODYNAMICS | UNKNOWN | H787114031015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |