MAUDE Adverse Event Report: ANGIODYNAMICS VENCURE NEVERTOUCH; ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	H787514030020
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of the fiber lock not attached to the fiber could not be confirmed because no sample was returned for evaluation.As a device evaluation could not be performed, a root cause for the reported complaint description cannot be determined.Without receiving product to evaluate, we cannot confirm the presence glue on the fitting.Though no issues were found in when reviewing the lot history records, the department responsible for bonding the fitting to the venacure fiber have been made aware of this complaint.A lot history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process the presence of glue fillets on the fiber fitting is 100% inspected and also receives one aql inspection.In addition to those inspections, the tensile strength of the fitting on each fiber is tested.The instructions for use, which is supplied to the end user with this catalog number contains the following statement; "properly attach the sterile, single use disposable nevertouch laser fiber by removing the protective cap and completely screwing the fiber fitting to lasers' sma 905 connector until tight and secure.Remove fiber stop assembly.Pull the sheath back and lock it to the sheath-lok fitting.Confirm location of the fiber using ultrasound guidance." 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.Complaint # (b)(6).
Event or Problem Description
As reported to angiodynamics on august 30, 2017: at the close of an evlt procedure, it was noted the fiber stop on the fiber shaft had detached, causing the fiber to shift.It was reported there was no harm or injury to the patient due to this event.The procedure was successfully completed prior to the fiber stop detaching.It was reported the disposable device is not available for return to the manufacturer for a device evaluation.

• Brand Name: VENCURE NEVERTOUCH
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6882514
• Report Number: 1319211-2017-00087
• Device Sequence Number: 891452
• Product Code: GEX
• UDI-Device Identifier: H787514030020
• UDI-Public: H787514030020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: Physician
• Device Catalogue Number: H787514030020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1