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	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.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 with an evlt kit with spotlight ops sheath 25cm.While unpacking the device for a procedure, it was noted that the tip appeared to be damaged.The device was not used and the procedure was completed with another same device.There was no reported patient harm or adverse event as a result of this incident.The reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 25cm laser fiber.The fiber was noted to have a break 7mm of the distal tip end.There was no sign of damage to the fiber buffer layer on either side of the break and there is very little distortion of the buffer at the break point indicating a very localized force caused the break.At the break point, the fiber glass core is flat and smooth indicating the fiber failure does not appear to be a stress related break.There is no spiral wrap (which protects the tip area) on the returned assembly.The customer's reported complaint description is confirmed.The returned sample shows a fracture/break at the distal tip.Although the complaint is confirmed, a definitive root cause cannot be determined.It was unable to be determined if the fiber was damaged prior to the packaging operation or if the break occurred as a result of mishandling after the fiber assembly was packaged.Since the plastic spiral wrap was removed from the returned fiber assembly, it is very possible that the break could have resulted from mishandling when removing the section of spiral wrap from the coiled fiber assembly.There is no way to determine exactly when the break occurred but the root cause appears to be mishandling.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.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".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 25CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 12299936
• Report Number: 1319211-2021-00057
• Device Sequence Number: 17081659
• Product Code: GEX
• UDI-Device Identifier: H787EVLT25OPS5
• UDI-Public: H787EVLT25OPS5
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 03/31/2024
• Device Catalogue Number: EVLT25OPS
• Device Lot Number: 5670983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1