MAUDE Adverse Event Report: ANGIODYNAMICS, INC OPS FIBER 55CM SPOTLIGHT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	H787EVLT55OPS5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was a fiber and a sheath.Both devices were fractured into two pieces and the sheath shaft contained a kink.The fiber tip end had noted discoloration which appeared to be burned.The customer's reported complaint description of fiber fractured was confirmed.A review of the returned sample shows a fracture in the fiber and burnt/melted sheath.The fiber fractured during the procedure resulting in laser energy escaping and melting the sheath.There was a kink observed in the sheath so handling damage during use is a potential root cause for the fiber fracture.A review of the lot history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.At the vendor facility, during the manufacturing process, fibers are repeatedly bent and coiled and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to shipment.During the packaging step, the fibers are inspected for damage.The directions for use which is supplied to the end user with this catalog number, contains the following statement "the end user is to align the compression clamp with the proximal site mark on the fiber and then tighten the compression clamp.The sheath is then to be withdrawn (with optical fiber) at a rate consistent with the venous anatomy".A review of the angiodynamics complaint system noted no trends for this complaint type and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).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: during an evlt procedure, it was noted the fiber appeared to be charred.The procedure was aborted due to this event.There was no report of patient harm or injury.The disposable device has been returned to the manufacturer for a device evaluation.

• Brand Name: OPS FIBER 55CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7907017
• Report Number: 1319211-2018-00099
• Device Sequence Number: 1438075
• Product Code: GEX
• UDI-Device Identifier: H787EVLT55OPS5
• UDI-Public: H787EVLT55OPS5
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: H787EVLT55OPS5
• Device Lot Number: 5353619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1