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

Catalog Number H787EVLT/PVAK5

Device Problems Bent (1059); Crack (1135); Device Damaged Prior to Use (2284)

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

Event Date 10/27/2016

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 evaluation.

Event Description

As reported (b)(6) 2016, a patient of unknown age and gender presented for an endovenous laser procedure.During preparation for the procedure, when the laser fiber was removed from the sterile packaging, it was noted the fiber was fractured.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient due to the event as the device did not come into contact with the patient.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 device wasn ot returned, angiodynamics was unable to perform a device evaluation.However, the end user did provide a photograph of the defect.The customers reported complaint of a fiber broken is confirmed based on the photographic evidence provided.A review of the lot history records was performed for the packaging lots, obtained via ship history, for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.At the vendor facility, during the manufacturing process, fibers are repeatedly bent and coiled and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to shipment.During the packaging step at angiodynamics, the fibers are inspected for damage.It is unlikely that the fiber was fractured prior to packaging.Although it cannot be definitively determined, the most likely root cause for this event is due to handling damage during transit or within the customer's facility.He 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, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6155955
• MDR Text Key: 61870495
• Report Number: 1319211-2016-00164
• 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 Technologist
• Type of Report: Initial,Followup
• Report Date: 03/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: H787EVLT/PVAK5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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