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

Catalog Number	H787114030030
Medical Device Problem Codes	Crack (1135); Fracture (1260); Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).Device not returned to date.
Event or Problem Description
As reported (b)(6) 2017:when prepping for an evlt procedure, when opening the sterile packaging, it was noted the laser fiber was bent.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.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was 25 cm fiber.A visual review of the fiber notes a kink(fracture), 148 cm from the tip.Functional testing could not be performed due to the condition of the device.The customer's reported complaint description of a bent (fractured) fiber is confirmed.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.A possible contributing factor could be due to user technique.As stated in the ifu "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 20 cm." although this theory cannot be definitely determined it does not appear to be design or manufacturing related.Adequate process controls are in place to detect this failure.The fracture was noticed during preparation and the patient was unaffected due to this event.A lot history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Prior to packaging, all components are inspected for 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.(b)(4).

• Brand Name: VENCURE NEVERTOUCH
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6325247
• Report Number: 1319211-2017-00018
• Device Sequence Number: 13717270
• Product Code: GEX
• UDI-Device Identifier: H787114030030
• UDI-Public: H787114030030
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

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 Expiration Date: 10/31/2019
• Device Catalogue Number: H787114030030
• Device Lot Number: 5099482
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1