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	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported an issue with an evlt kit with spotlight ops sheath 25cm.During a gsv procedure, the fiber broke while inside of the patient.The patient required surgery to remove the fragment.Apart from surgery, it was reported that the patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of fiber detached inside patient is not confirmed as the complaint sample was not returned.Without receiving a fiber sample for evaluation a definitive root cause cannot be determined.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.The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.The review confirmed that the packaging lots met all material, assembly, and performance specification.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).Note: the initial mdr for this event was submitted on november 18, 2021.When submitting the final report, the acknowledgements indicated the initial report was not received, although the initial report acknowledgments stated the report had passed.Therefore, as a resolution to the issue, the initial report is being resubmitted an includes the investigation results.Core id: (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
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13087342
• Report Number: 1319211-2021-00080
• Device Sequence Number: 5711392
• Product Code: GEX
• UDI-Device Identifier: H787EVLT25OPS5
• UDI-Public: H787EVLT25OPS5
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EVLT25OPS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown