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

Catalog Number H787EVLTPVAK5

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

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

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint #(b)(4).

Event Description

As reported august 21, 2017 to angiodynamics: 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.The reported disposable device has been returned to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was an evlt/ pvak fiber.A visual inspection noted that the fiber was fractured.Angiodynamics' supplier was informed of this event via (b)(4).The patient was unaffected due to this event.The customer's reported complaint of a broken fiber is confirmed.The patient was unaffected due to this event as the defect was noted out of package.The most likely root cause to this event is due to handling after the device left the angiodynamics facility.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.Per the vendor response, 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, the fibers are inspected for damage.It is unlikely that the fiber was fractured prior to packaging.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.Complaint # (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: 6797884
• MDR Text Key: 82935618
• Report Number: 1319211-2017-00081
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: H787EVLTPVAK5
• Device Lot Number: 5186788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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