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

Catalog Number EVLT/PVAK

Device Problems Kinked (1339); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

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.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.

Event Description

As reported, on (b)(6) 2014, a patient of unknown age and gender presented for an endovenous laser procedure.During preparation of an evlt/pvak procedure, the doctor noticed that the fiber was kinked in the packaging.The device was set aside and a new of the same device.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 available for return to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was a evlt/pvak fiber.A visual evaluation of the disposable device noted the fiber was fractured into two pieces.The customer's reported complaint description is confirmed.A root cause fo the complaint description cannot be definitively 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 radius of 60mm" during the manufacturing process, the device goes through several aql inspections.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.A review of the angiodynamics complaint system noted no 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.; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5263520
• MDR Text Key: 32676056
• Report Number: 1319211-2015-00371
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K002101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: EVLT/PVAK
• Device Lot Number: 006140
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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