MAUDE Adverse Event Report: ANGIODYNAMICS OPS FIBER 80CM SPOTLIGHT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	EVLT80OPS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An angiodynamics territory manager reported an issue with an evlt kit.During preparation, it was noted that the fiber was broken, upon opening.The device was set aside and the procedure was completed with another same device and there was no report of patient harm or adverse event, by the end user.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of fiber broken/fractured cannot be confirmed as no product was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the incoming lot history records was performed for the reported packaging lots for any deviations related to the reported defect of the complaint.The review confirms that the lot 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, the fibers are inspected for damage.It is unlikely that the fiber was fractured prior to packaging.The most likely root cause to this event is due to handling after the device left the angiodynamics facility.Labeling review: 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.Reference(b)(4).

• Brand Name: OPS FIBER 80CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10927134
• Report Number: 1319211-2020-00082
• Device Sequence Number: 982679
• Product Code: GEX
• UDI-Device Identifier: H787EVLT80OPS5
• UDI-Public: H787EVLT80OPS5
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K041957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: EVLT80OPS
• Device Lot Number: 5558146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1