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

Catalog Number	H787114030130
Medical Device Problem Code	Uncoiled (1659)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
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.Complaint # (b)(4).Device has not been returned to date.
Event or Problem Description
As reported on (b)(6) 2016, during an evlt procedure , the treating physician had already accessed the gsv vein and was attempting to thread the guidewire through the vein.While withdrawing the guidewire due to difficulty advancing, it uncoiled as the physician pulled the wire out from the needle.The guidewire was removed without any fragments left inside of the patient.It was set aside and the procedure was successfully completed using 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
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of the guidewire unraveling 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that a needle is used to puncture the structure and a guide wire is threaded through the needle; when the needle is withdrawn, a catheter is threaded over the wire; the wire is then withdrawn, leaving the catheter in place.Additionally, the ifu states to remove the needle before the guidewire.It was noted that the patient suffered no harm or injury due to this event.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.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; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6242051
• Report Number: 1319211-2017-00001
• Device Sequence Number: 954710
• Product Code: GEX
• UDI-Device Identifier: H787114030130
• UDI-Public: H787114030130
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Medical Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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 Catalogue Number: H787114030130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1