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

Catalog Number H787114030120

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference # (b)(4).

Event Description

As reported to angiodynamics on (b)(4) 2017: when prepping for an endovenous laser procedure, when opening the sterile packaging, it was noted the laser fiber was bent in half and not usable.The device was set aside and anew of the same was used to complete the procedure.It was reported the disposable device is not available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

As the disposable device was not returned, angiodynamics is unable to perform a device evaluation.However, based on photographs provided by the user, the customer's reported complaint description of a bent fiber is confirmed.A root cause for the complaint description cannot be determined.A possible contributing factor could have been due to user technique.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 20cm." although this theory cannot be definitely determined it does not appear to be design or manufacturing related.Adequate process controls are in place to detect this failure.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.A review of the 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: "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".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.Complaint reference (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 ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6935054
• MDR Text Key: 90069120
• Report Number: 1319211-2017-00105
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114030120
• UDI-Public: H787114030120
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: H787114030120
• Device Lot Number: 5213960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1