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

Catalog Number	H787114030010
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
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
As reported to angiodynamics on may 31, 2018: nearing end of an evlt treatment procedure, the user reported they started to smell a burning odor.As the treating physician removed the catheter from the patient, the tip of the catheter appeared to be burnt.The fiber was locked into place with the catheter.As the catheter was unlocked and the fiber was removed, the tip of the catheter broke off.The patient suffered no harm or injury due to this event as the device had been removed at the time of 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 a fiber and tre-sheath.With the returned product, there was (black) loose particulate at the bottom of the biohazard bag.A visual examination of the returned devices noted the tip of the tre-sheath contained foreign matter, and the fiber (gold) tip was coated with a black substance (dried blood).There was no noted damage or defects to the fiber.The tre-sheath was cleaned, and the tip was fully intact with no noted defects.An attempt to advance the fiber through the tre-sheath was successful and no resistance was met.Both devices met all manufacturing dimensional specifications for these products.The reported complaint description of "the tip of the sheath broke off", is not confirmed.During the investigation it was noted there was a black substance at the tip of the sheath and the foreign matter at the bottom of the bag of returned product, engineering confirmed this was biological matter.No burn damage to the sheath tip was observed.The root cause for the reported complaint description of tip fracture is not required as there was no tip fracture.The most likely root cause for the for the event is when the fiber was being fired, the biological matter built up at the fiber tip and caused the bio matter to burn which is why the burning smell was detected.A review of the angiodynamics' 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.The instructions for use, which is supplied to the end user with this catalog number, state "advance the 4fr trè-sheath introducer, over the wire, to the treatment location.If treating the great saphenous vein, position sheath tip so that it is 1-2cm below the sapheno-femoral junction.Verify sheath positioning using ultrasound guidance.Remove the dilator and guidewire.Flush the sheath with normal saline.Properly attach the sterile, single use disposable nevertouch laser fiber by removing the protective cap and completely screwing the fiber fitting to lasers' sma 905 connector until tight and secure.Insert the nevertouch laser fiber into the sheath until the fiber stop assembly comes in contact with the proximal end of the sheath hub." 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.Reference complaint #(b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7638941
• Report Number: 1319211-2018-00060
• Device Sequence Number: 1861565
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: H787114030010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1