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

Catalog Number H787EVLT/PVAK5

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

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

Event Date 02/20/2017

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.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).Device not available for return.

Event Description

As reported to angiodynamics on (b)(6) 2017: when prepping for an evlt procedure, it was noted the aiming beam was showing through the shaft of the laser fiber.The device was set aside and a new of the same was used to perform the evlt procedure.There was no patient contact with the defective device.It was reported the disposable device is not available for return to the manufacturer as it was disposed of by the user.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customers reported complaint of the beam illuminating out of the fiber shaft could not be confirmed because the sample was not returned for evaluation.The event was most likely due to a fractured fiber.Without receiving product to evaluate, a root cause to the fracture cannot be determined.A review of the incoming lot history records was performed for the reported packaging lots for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly, and performance specifications.Angiodynamics' vendor was made aware of this complaint.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.The directions for use which is supplied to the end user with the reported 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, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6384314
• MDR Text Key: 69273160
• Report Number: 1319211-2017-00033
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: H787EVLT/PVAK5
• Device Lot Number: 5087682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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
• Patient Age: 35 YR