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

Catalog Number	H787114030130
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
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.Complaint reference: (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: a patient presented for an endovenous laser treatment procedure.Before the doctor put the laser in the catheter, he noticed a break and red light appearing through the middle.The defect was noted prior to placement into the patient.The device was set aside and a new of the same device was used to complete the procedure.It was reported the disposable device is not available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an nevertouch fiber.A visual review of the fiber noted that the tip was cracked.When visually compared to a known good sample, the damage was obvious.During functional testing, the fiber was connected to a laser unit, and the aiming intensity was set at 3.The aiming beam could be visualized and the fiber end was glowing.The customers complaint of "the fiber break and red light appearing through the middle of fiber" was not confirmed, however the red light "glow" appeared at the end of the fiber.The most likely root cause for this event is handling damage after leaving the angiodynamics manufacturing facility.The fiber tips contain a glass ferrule and should be handled with care.The returned fiber possessed damage to the glass ferrule in the fiber tip.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.During the manufacturing of the disposable fiber, each fiber receives a tip protector.The tip protector remains on the fiber until the packaging process.The instructions for use which is supplied to the end user with this catalog number contains the following sentence; "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: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7411786
• Report Number: 1319211-2018-00036
• Device Sequence Number: 16345193
• Product Code: GEX
• UDI-Device Identifier: H787114030130
• UDI-Public: H787114030130
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 11/30/2020
• Device Catalogue Number: H787114030130
• Device Lot Number: 5266572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1