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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable device was discarded by the user and 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.(b)(4).

Event Description

As reported to angiodynamics on may 12, 2017: dr.Miller turned the aiming beam on before loading into the sheath and the fiber appeared to be visually broken near the frs connector.He decided not to use it and opened another kit and completed the procedure.No harm to patient.It was reported the disposable device is not 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 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" 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.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
• MDR Report Key: 6618849
• MDR Text Key: 76917278
• Report Number: 1319211-2017-00060
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: H787114030020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1