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

Catalog Number	H787114030130
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on april 17, 2018: upon withdrawing the laser fiber during an evlt procedure, it was noted the fiber tip had melted the sheath.The customer said the luer lock did not come loose and the laser was hubbed to the catheter.No piece of the sheath had melted off.There was no patient impact to the patient as this occurred outside of the patient.It was indicated the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The end user provided photos of the defective device.In the photo, it appeared that light was emitting from a few separate points along the fiber shaft.It was unclear as to whether the gold tip had detached, if the sheath and fiber lengths were correct, or if the sheath lok fitting had moved.These three scenarios would contribute to a sheath burn.The reported complaint description of "the fiber burned the tre-sheath while removing the fiber" is confirmed based on the provided customer photos.However without product being returned, a definitive root cause for the burnt sheath cannot be determined.A possible contributing factor could have been that the fiber had fractured and if that occurred, light would most likely exit the fiber from multiple points, resulting in burning of the sheath.A review of the 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.The instructions for use, which is supplied to the end user with this catalog number, states: "prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending.Do not coil the fiber tighter than a diameter of 20cm.Clinical safety and effectiveness data is not available for other fiber tip designs and diameters.Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage".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 complaint #(b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7518023
• Report Number: 1319211-2018-00048
• Device Sequence Number: 1425607
• Product Code: GEX
• UDI-Device Identifier: H787114030130
• UDI-Public: H787114030130
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K162914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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 Expiration Date: 11/30/2020
• Device Catalogue Number: H787114030130
• Device Lot Number: 5276800
• 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: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1