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

Catalog Number	H787114030010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was a nevertouch fiber.Noted on the fiber shaft was a bend 84cm from fiber tip.The fiber was connected to a diomed laser and stated, "fiber uses expired".This indicates that the fiber had been fired.The customer's reported complaint description of the fiber fracturing is confirmed.A review of the returned sample shows the shaft of the fiber is bent; this could occur when handling.As stated in the ifu "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm.".A definitive root cause for the fracture cannot be determined.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.Prior to packaging, all components are inspected for damage.The instructions for use, which is supplied to the end user with this catalog number contains the following statement: "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.Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage".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).
Event or Problem Description
A sample was received on august 12 2019.Multiple good faith efforts were made to identify the complaint record for the returned sample.The return label on the package contained a phone number, which was called.Several messages were left, but no response was received.This complaint file was opened to document the returned device using the account name on the return label.The device was opened for evaluation on (b)(6), at which time it was noted the fiber was fractured.As it cannot be determined of the fracture occurred at the user facility or during shipping to angiodynamics for evaluation of an unknown issue, this pr has been deemed reportable as a precaution.The aware date for this device will be based on (b)(6) 2019 as this is the date the fracture was noted.Sample evaluation description: the fiber is bent/fractured measured at 84cm from tip end and the laser shows the sample was fired.

• 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: 9179287
• Report Number: 1319211-2019-00095
• Device Sequence Number: 16798195
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: H787114030010
• Device Lot Number: 5465568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1