MAUDE Adverse Event Report: ANGIODYNAMICS VENACURE EVLT SPOTLIGHT OPS; ENDOVENOUS LASER TREATMENT FIBER

Catalog Number EVLT/55-OPS

Device Problem Kinked (1339)

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

Event Date 12/09/2013

Event Type  malfunction  

Event Description

As reported (b)(6) 2014 a patient of unk age and gender presented for an endovenous laser procedure.It was reported that when opening the sterile packaging during preparation for the procedure, it was noted that the dilator was kinked in the package.The disposable 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 this event as the device did not come into contact with the patient.The reported device has been returned to the mfr for evaluation.An evaluation of the returned device noted that it was the fiber that was kinked, not the dilator.

Manufacturer Narrative

Returned for evaluation was an evlt fiber.A visual examination of the fiber noted that the fiber was kinked.The complainant's initial reported complaint description was for a kinked sheath.Upon examination of the device, the complaint was verified with the customer as a kinked fiber issue.The customer's reported complaint description is confirmed.A definitive root cause for the complaint description cannot be determined; however, it does not appear to be mfg related.The most likely root cause is handling damage after the device left the mfg facility.A review of the lot history records was performed for the reported lot for any deviations.The review confirms that the lots met all material, assembly, and performance specifications.During the mfg 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 packaging shipment.The exact root cause of the event cannot be determined at this time, although it is unlikely that the kit was packaged with the broken component.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: VENACURE EVLT SPOTLIGHT OPS
• Type of Device: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 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: 3970282
• MDR Text Key: 4635007
• Report Number: 1319211-2014-00059
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: EVLT/55-OPS
• Device Lot Number: 006086
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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