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

Catalog Number	H787114030010
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event 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As reported to angiodynamics on (b)(6) 2018, during the evlt procedure, the fiber and sheath were withdrawn from the patient as one unit.When the physician was preparing to treat the patient's second vein, it was noted the gold tip of the laser fiber had detached inside of the sheath.As the tip was inside of the sheath, the patient suffered no adverse effects due to the event.The disposable device has been returned 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 had detached from the fiber and remained in the end of the tre-sheath.Microscopic inspection of the fiber noted evidence of crimp marks and adhesive, indicating the fiber had been manufactured correctly.The customer's reported complaint description of the gold tip detaching from the fiber is confirmed.A definitive root cause cannot be determined at this time, although it does not appear to be manufacturing related.The most likely root cause is mishandling of the fiber by the end user during the ablation of the gsv.A lot history records search for the nevertouch kit 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.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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference pr (b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7305636
• Report Number: 1319211-2018-00020
• Device Sequence Number: 16453285
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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 Expiration Date: 10/31/2020
• Device Catalogue Number: H787114030010
• Device Lot Number: 5261549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1