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

Catalog Number H787114030020

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2017

Event Type  malfunction  

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 Description

As reported to angiodynamics on may 02, 2017: during preparation for an evlt procedure, when the laser fiber was removed from its sterile packaging, it was noted the fiber had fractured.The device was set aside and the procedure was successfully completed with a new of the same device.There was no patient involvement with the fractured laser fiber.It was reported the disposable device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of a fractured fiber cannot be confirmed because no sample was provided.Without receiving a sample to evaluated, a root cause cannot be determined.A lot history records search for the nevertouch kit and the fiber sub-assembly revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, the disposable fiber device receives two 100% inspections and an aql inspection in which the quality of the fiber strip is inspected.It is highly unlikely that the product was package with this defect.Adequate process controls are in place to detect this failure.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" and "pull the sheath back and lock it to the sheath-lok fitting." 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.(b)(4).

• Brand Name: VENCURE NEVERTOUCH
• Type of Device: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6572942
• MDR Text Key: 75452145
• Report Number: 1319211-2017-00057
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114030020
• UDI-Public: H787114030020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: H787114030020
• Device Lot Number: 5154630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1