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

Catalog Number	H787114030010
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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 08.2018: the treating physician withdrew the fiber and the sheath from the patient as one unit.When disassembling in order to flush and clean it, the tip of the fiber appeared to be stuck inside of the sheath.It was noted the tip had melted to the inside of the sheath.The device was set aside and the procedure was successfully completed witha new of the same device.There was no harm or injury to the patient due to this 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 nevertouch fiber.A visual review of the fiber noted that the gold tip tube had detached from the fiber and was stuck in the end of the tre-sheath.The returned devices met all manufacturing dimensional specifications for this product.The customer's reported complaint description of the "tip of the fiber lodged the sheath tip" is confirmed; the sheath was not melted.Evaluation of the returned sample confirmed the fiber was manufactured correctly, as evidenced by proper crimp marks on the tube tip and adhesive present.This is also supported by the fact that there were no issues reported with the use of the fiber/sheath during the first vein ablation.A definitive root cause cannot be determined at this time, although a possible contributing factor could be due to a buildup of biological matter (dried blood) in the tre-sheath that occurred during the ablation.This buildup prevented fiber tip from being pulled back into the sheath at the end of the first vein ablation.The end user then pulled back on the fiber which resulted in the tip detaching from the fiber shaft.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, contains the following statement "precaution: 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.Clinical safety and effectiveness data is not available for other fiber tip designs and diameters." 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: 7569888
• Report Number: 1319211-2018-00059
• Device Sequence Number: 2678093
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1