MAUDE Adverse Event Report: ANGIODYNAMICS EVLT KIT WITH SPOTLIGHT OPS SHEATH; ENDOVENOUS LASER TREATMENT FIBER

Catalog Number EVLT/55-OPS

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2015

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.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.(b)(4).

Event Description

As reported on (b)(6) 2015, a patient of unknown age and gender presented for an endovenous laser procedure.During preparation for the procedure, when opening the sterile packaging, it was noted the fiber was kinked inside of the packaging.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 the event as the disposable device did not come into contact with the patient.The disposable device has been returned to the manufacturer for evaluation.

• Brand Name: EVLT KIT WITH SPOTLIGHT OPS SHEATH
• Type of Device: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4576207
• MDR Text Key: 19065765
• Report Number: 1319211-2015-00123
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVLT/55-OPS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• 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