MAUDE Adverse Event Report: ANGIODYNAMICS OPS FIBER 55CM SPOTLIGHT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	EVLT55OPS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 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
A vascular surgeon reported an issue with a evlt kit with spotlight ops sheath 55cm.During procedure closure, when withdrawing the fiber from the patient, after treating a 30cm gsv, it was noted that the fiber was broken at the 2cm distal mark.The fiber was fully fractured, but still attached to the rest of the fiber.It is fractured around the part that is outside the sheath.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.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 aevlt fiber.A visual examination of the fiber noted the fiber was fractured 1.3cm from the tip.There were no signs of any thermal degradation at the break point.The entire length of the returned fiber assembly was stressed by bending it to approximately a 1/2" radius and no weak points were found.Per the manufacturing engineer's evaluation: "due to these observations, it appears that some type of very localized force was applied to the fiber during withdrawal which initiated the break.If a fiber glass core is scored by a sharp object while under stress, it is possible for a break to occur at the score mark that will have a flat appearance across the surface of the break.This along with the buffer having a clean cut appearance at the break point leads me to believe that some type of sharp instrument may have been used to assist with withdrawal of the sheath / fiber assembly and it contacted the exposed section of fiber which created a condition that resulted in the observed failure." the customer's reported complaint description of the fiber fractured is confirmed.A definitive root cause for the fracture cannot be established, however, it is most likely due to handling after the fiber left the manufacturer's facility.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.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Labeling review: the directions for use which is supplied to the end user with the reported 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".The user manual (man/31/0075 us), which is supplied to the end user with this unit, states "before using a fiber, check it carefully for any signs of damage during storage or transit.Protective caps should be in place over sma connectors.Do not use if there is any sign of damage." 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 55CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11429674
• Report Number: 1319211-2021-00015
• Device Sequence Number: 2857319
• Product Code: GEX
• UDI-Device Identifier: H787EVLT55OPS5
• UDI-Public: H787EVLT55OPS5
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 02/28/2023
• Device Catalogue Number: EVLT55OPS
• Device Lot Number: 5580974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR