MAUDE Adverse Event Report: ANGIODYNAMICS VENACURE NEVERTOUCH DIRECT PROCEDURE KIT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	11403101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an issue with a never touch direct procedure kit.During a procedure, the fiber broke and the part of the fiber, with the golden tip, is retained in the patient's leg.The doctor reported that the patient will have to perform a separate surgery if the decision is made to remove the fiber tip from the patient's leg.The procedure was completed with another same device.
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
Event description updated based on new information: a distributor reported an issue with a nevertouch direct procedure kit.During a procedure, the fiber broke and the part of the fiber, with the golden tip, is retained in the patient's leg and detected by x-ray.The doctor reported that the patient will have to perform a separate surgery if the decision is made to remove the fiber tip from the patient's leg.The procedure was completed with another same device.Per additional information provided, according to the most recent examination, the fiber has moved to the abdominal veins.Because the removal is relatively complicated and the patient's health is stable, the doctor decided to regularly check and not perform surgery to remove the severed part from the patient's body.
Additional Manufacturer Narrative
Returned for evaluation was a nevertouch direct fiber.A visual review of the fiber noted that the fiber was fractured 6mm from the proximal end of the gold tip tube.The distal portion of the fiber with the gold tip was not returned for evaluation (retained in patient).The customer's reported complaint of the distal portion of the fiber was fractured/detached is confirmed.Although the complaint description is confirmed, a defnitive root cause for the fracture could not be determined.A device history records search for the nevertouch direct kit revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Prior to packaging, all components are inspected for damage.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm." 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).

• Brand Name: VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13011303
• Report Number: 1319211-2021-00088
• Device Sequence Number: 16617934
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2022

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 11403101
• Device Lot Number: 5644386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/30/2021; 02/16/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/04/2022; 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male