MAUDE Adverse Event Report: ANGIODYNAMICS OPS FIBER 25CM SPOTLIGHT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	EVLT25OPS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional 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 investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue when opening an evlt 25ops fiber for an evlt procedure.When the sterile package was opened, it was noted by the physician that the 25 cm ops fiber was kinked and broken.The fiber was set aside and a new fiber pack was opened.The procedure was successfully completed with the new fiber with no harm or injury to the patient.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was an evlt fiber.The returned fiber was returned coiled with the lock, noted to have a break approximately 26mm from the fiber tip.The fiber was connected to the tagwrite and noted to have not been used.The fiber break occurred 26mm from the distal tip.The break does not appear to have occurred under a high degree of stress due to the relatively smooth ends of the glass core and minimal distortion to the buffer at the break point.The customer's reported complaint of fiber fractured is confirmed.The returned unused fiber was noted to have a fracture 26mm from the fiber tip.A possible root cause of the fracture could be that the fiber had a flaw.Another possible root cause could be end user handling when trying to remove the coil wrap since the fracture is located right next to the coil.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.A review of the device packaging 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.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.(b)(4).

• Brand Name: OPS FIBER 25CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10984139
• Report Number: 1319211-2020-00085
• Device Sequence Number: 3234527
• Product Code: GEX
• UDI-Device Identifier: H787EVLT25OPS5
• UDI-Public: H787EVLT25OPS5
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: health professional,user faci
• 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: 03/31/2023
• Device Catalogue Number: EVLT25OPS
• Device Lot Number: 5591385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/10/2020
• 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
• Patient Age: 47 YR