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	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event 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
During preparation for the procedure, when opening the sterile packaging, it was noted the laser fiber broken in half and introducer sheath was deformed/kinked.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient due to the event.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a nevertouch evlt fiber.A visual evaluation of the disposable device noted the fiber was fractured.The customers reported complaint of the fiber was broken is confirmed.A review of the returned sample shows the glass core at the break of the fiber is relatively flat indicating that the fiber broke under a low level of stress.Although the complaint is confirmed, an exact root cause of the failure cannot be determined.The fiber material was either adversely affected by handling during the procedure which weakened it or there was an inherent flaw in the fiber glass core which resulted in a break when handling the fiber assembly.A review of the angiodynamics' device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots 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 "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60mm".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 12804
• MDR Report Key: 8474751
• Report Number: 1319211-2019-00022
• Device Sequence Number: 19158358
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 02/29/2020
• Device Catalogue Number: H787114031015
• Device Lot Number: 5154638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1