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

Catalog Number	H787114030060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/24/2016
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).
Event or Problem Description
Received notification from (b)(6) on july 05, 2016 via usps, (b)(4).As reported ,a patient of unknown age and gender presented for an endovenous laser procedure of the left leg.During the procedure, the treating physician used ultrasound to guide the tip of the laser fiber.While doing so, it was noted the laser fiber was not emitting steam bubbles.The physician withdrew the laser fiber which appeared to be blackened and fractured.A piece of the laser fiber remained inside of the patient.The fractured piece was successfully removed via cutdown.It was reported the patient suffered no permanent harm or injury due to the event.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
The reported defective device was not returned to the manufacturer for a device evaluation as it was disposed of by the user.The customer's reported complaint description of a fractured fiber could not be confirmed because no sample was returned for evaluation.Without receiving product to evaluate, a root cause cannot be determined.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 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 20cm." although this theory cannot be definitely determined it does not appear to be design or manufacturing related.Adequate process controls are in place to address this failure.The instructions 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 diameter of 20cm" 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.Complaint # (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: 5842831
• Report Number: 1319211-2016-00106
• Device Sequence Number: 16210817
• Product Code: GEX
• UDI-Device Identifier: H787114030060
• UDI-Public: H787114030060
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2016

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: 02/28/2019
• Device Catalogue Number: H787114030060
• Device Lot Number: 4991594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 12/20/2016
• 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