MAUDE Adverse Event Report: ANGIODYNAMICS EVLT/80-OPS; ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	EVLT/80-OPS
Medical Device Problem Codes	Crack (1135); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2016
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.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.(b)(4).
Event or Problem Description
As reported (b)(6) 2016, a patient of unknown age and gender presented for an endovenous laser procedure.During preparation for the procedure, when the laser fiber was removed from the sterile packaging, it was noted the fiber was fractured.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 as the device did not come into contact with the patient.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective fiber was not returned, angiodynamics is unable to perform a device evaluation.The customers reported complaint of a broken fiber is unable to be confirmed since no product was returned for evaluation.Without receiving product to evaluate, we are unable to definitively determine root cause for this event.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.The vendor was made aware of this via a scar.Their response contains the statement: "the current evlt product has some inherent design elements that leave the fiber vulnerable to breakage during handling and use due to the presence of the stripped fiber.Throughout the manufacturing, cleaning and coiling processes, there are procedures in place that protect the fiber from breakage and maintain fiber integrity and robustness through formal inspection and shipment to the customer.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.It is unlikely that the fiber was fractured prior to packaging.The most likely root cause to this event is due to handling after the device left the angiodynamics facility.The directions 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 60 mm".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.(b)(4).Device unavailable for return.

• Brand Name: EVLT/80-OPS
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5664411
• Report Number: 1319211-2016-00082
• Device Sequence Number: 10822265
• Product Code: GEX
• UDI-Device Identifier: H787EVLT80OPS5
• UDI-Public: H787EVLT80OPS5
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2016

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: 08/31/2018
• Device Catalogue Number: EVLT/80-OPS
• Device Lot Number: 4994817
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 01/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1