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

Catalog Number EVLT25OPS

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2021

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 282772605
• Report Number: 1319211-2021-00080
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787EVLT25OPS5
• UDI-Public: H787EVLT25OPS5
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: EVLT25OPS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2021
• Initial Date FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other