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

Catalog Number	H787114031015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been 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 device evaluation will be sent via a follow up medwatch.Reference complaint # (b)(4).
Event or Problem Description
As reported: nevertouch fiber burned and fractured around 14 cm from the tip.Distal part had to be surgical removed.First treated was a aasv with 3200 joule.After this procedure the doctor wanted to treat the ssv and the fiber fractured after starting firing.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no permanent harm or injury to the patient due to the event.It was reported the disposable device has been returned to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a never touch direct fiber.A visual review of the fiber noted that the fiber was fractured.The break occurred approximately 12.5cm from the tip end.A review of the returned sample shows the buffer at the break point is stretched, twisted and burnt and the glass core reveals a degree of stress due to the angle of the break.Functional testing could not be performed due to the condition of the returned device.A definitive root cause for the reported complaint description cannot be determined, however, the reported event description indicated there were no issues during the first vein ablation and the event occurred shortly after starting the second vein ablation.Due to the angle of the fracture in the glass core, it appears the fiber experienced a degree of stress prior to the fracture of the fiber.Although a definitive root cause for the fracture cannot be determined it does not seem likely it was due to a manufacturing issue.The most likely root cause for the fracture is handling or technique used during the procedure.A review of the lot history records was performed for the reported never touch direct fiber for any deviation in the manufacturing process related to the reported defect of the complaint.The review confirms that the manufacturing lot met all material, assembly, and performance specifications.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.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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference complaint: (b)(4).

• Brand Name: NEVERTOUCH DIRECT PROCEDURE KIT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny NY 12804
• MDR Report Key: 9355744
• Report Number: 1319211-2019-00107
• Device Sequence Number: 11302271
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: H787114031015
• Device Lot Number: 5493839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR