MAUDE Adverse Event Report: ANGIODYNAMICS PVAK - 400 MICRON FIBER PROCEDURE KIT; ENDOVENOUS LASER TREATMENT FIBER

Catalog Number EVLT/PVAK

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2017

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).Device not returned to date.

Event Description

As reported to angiodynamics on may 01, 2017: during preparation for an evlt procedure, when removing the laser fiber from it' packaging, the fiber fractured.The device was set aside and a new of the same device was used to successfully complete the procedure.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 customers reported complaint of a fractured fiber could not be confirmed because no sample was returned for evaluation.A review of the lot history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Angiodynamics' supplier was made aware of the event via (b)(4), per the vendor's response: at the vendor facility, manufacturing and inspections procedures include a 100% inspection of the entire fiber, including the quality of each strip.Each unit is also repeatedly bent and coiled during the processing and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to packaging and shipment.During the hene laser test the fiber tip is examined closely for damage.Without receiving product to evaluate, the root cause cannot be determined, although it is unlikely that the fiber was fractured prior to packaging.The most likely root cause to this event is due to handling after the device left the angiodynamics facility.The directions 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 radius of 60mm".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: PVAK - 400 MICRON FIBER PROCEDURE KIT
• 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: 6572950
• MDR Text Key: 75413798
• Report Number: 1319211-2017-00058
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• 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: 09/30/2017
• Device Catalogue Number: EVLT/PVAK
• Device Lot Number: 5020192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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