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

Catalog Number	11403012
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.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 female patient of unknown age presented for an endovenous laser procedure.The procedure was successfully completed with no report of complications or device malfunction.When finishing the procedure, the treating physician withdrew the fiber, at which point, the fiber fractured.A piece of the fiber remained inside of the patient.The physician successfully removed the fractured piece from the patient.It was reported the patient suffered no permanent harm or injury due to the event.It was reported the disposable device is not available for return to the manufacturer for a device evaluation as it was disposed of by the user.
Additional Manufacturer Narrative
As the reported defective device 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 the reported device was not 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 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.A review of the lot 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: "cease operating the laser by removing foot from foot pedal when the fiber end is 2 - 3 cm from the access site as indicated by markers on the distal tip of the trè-sheath introducer." 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).

• Brand Name: VENCURE NEVERTOUCH
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5609253
• Report Number: 1319211-2016-00064
• Device Sequence Number: 562328
• Product Code: GEX
• UDI-Device Identifier: H787114030120
• UDI-Public: H787114030120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 11403012
• Device Lot Number: 4972224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2016
• Supplement Report FDA Received Date: 05/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention