MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; NEVERTOUCH FRS 65CM PROCEDURE KIT

Catalog Number	11403002
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint description of sheath tip was burned and detached was confirmed.The returned tre-sheath complaint sample was noted with the tip being burned.The root cause for the sheath tip burnt/detached issue was due to the end user's failure to remove the fiber stop assembly and connect the fiber's sheath-lok fitting to the tre-sheath hub.Per dfu 169000393-01, "insert the never touch laser fiber into the sheath until the fiber stop assembly comes in contact with the end of the sheath hub.Remove fiber stop assembly.Pull the sheath back and lock it to the sheath-lok fitting".When the tre-sheath hub is not connected to the fiber's sheath-lok fitting then it positions the fiber tip within the tre-sheath tubing rather than extending just distal to the sheath tip.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: directions for use (dfu, (b)(4) is provided with the fiber kit.Review of the returned complaint sample showed indication that the fiber was not used in accordance with its labeling since the fiber stop assembly was not removed and tre-sheath hub could not have been connected to the sheath-lok fitting.Dfu contains the following statements.Procedure: - insert the never touch laser fiber into the sheath until the fiber stop assembly comes in contact with the end of the sheath hub.[see picture in dfu] - remove fiber stop assembly.Pull the sheath back and lock it to the sheath-lok fitting.- confirm location of the fiber using ultrasound guidance.- the never touch fiber end should be 2 cm below the sapheno-femoral junction when treating the gsv.- move the sliding sheath gauge until flush with the insertion site, to mark the final position of the sheath.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).
Event or Problem Description
An end user reported the following issue with a never touch 65cm kit w/gripper and rfid t: customer (b)(6) contacted tm (b)(6) around 10am to report that dr (b)(6) was doing an evlt case on 3/8 and experienced a loss of the tre sheath tip (2-3cm's) upon completion of the procedure.I contacted the account at 10:45am and spoke with (b)(6) (rn).(b)(6) reported the patient was an approximately 65 y/o male undergoing evlt of a ssv with thigh extension.Doctor (b)(6) noted the missing sheath tip at the end of the procedure.(b)(6) reports that the laser fiber hub may have not been secured to the tre sheath hub prior to initiating treatment.Per (b)(6), patient was not reported to have suffered injury.Patient was seen yesterday for ultrasound follow-up.Sheath fragment noted to be present in the vein.Customer has been informed that the fragment should be removed; however, the patient voiced some resistance.At this time, the fragment remains in situ but an ultrasound has been scheduled for a future date.Despite the fragment, the patient has not experienced any adverse effects or harm as a result of this event.

• Brand Name: VENACURE EVLT
• Common Device Name: NEVERTOUCH FRS 65CM PROCEDURE KIT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18966553
• Report Number: 1319211-2024-00046
• Device Sequence Number: 6213604
• Product Code: GEX
• UDI-Device Identifier: H787114030020
• UDI-Public: H787114030020
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K231945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11403002
• Device Lot Number: 5810705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 03/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male