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

Catalog Number	11403006
Medical Device Problem Codes	Uncoiled (1659); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2016
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.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 the procedure, while pulling the guidewire back through the needle, the guidewire was damaged.No piece of the guidewire remained inside of the patient.The device was set aside and the procedure was successfully completed with a new of the same device.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
The customer's reported complaint description of the guidewire becoming seriously damaged could not be confirmed because no sample was returned for evaluation.Although no sample was returned, based on information provided in the complaint description, the root cause to this complaint is most likely due to the guidewire being pulled through the needle.Standard seldinger technique states that a needle is used to puncture the structure and a guide wire is threaded through the needle; when the needle is withdrawn, a catheter is threaded over the wire; the wire is then withdrawn, leaving the catheter in place.A lot history records review revealed no quality related issues or manufacturing deficiencies at the time of manufacture.A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) device not available for return.

• Brand Name: VENCURE NEVERTOUCH
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5706140
• Report Number: 1319211-2016-00091
• Device Sequence Number: 18837061
• Product Code: GEX
• UDI-Device Identifier: H787114030060
• UDI-Public: H787114030060
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2016

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: 12/31/2018
• Device Catalogue Number: 11403006
• Device Lot Number: 4967880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1