MAUDE Adverse Event Report: ANGIODYNAMICS OPS FIBER 25CM 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	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
A physician reported an issue with an evlt kit with spotlight ops sheath 55cm.While unpacking the fiber, it was noted that it appeared to be bent at a 90 degree angle.When the physician attempted to straighten the device, it broke immediately.The patient was on the table when this occurred; however, there was no significant delay.The patient did not experience any adverse effects, harm, or require medical intervention because 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 evlt spotlight ops 55cm fiber.There was a noted fracture of the fiber that measured 137.5cm from the fiber tip.Per the manufacturing engineer for this product, "it is anticipated that the fiber material may have some flaws within the glass core which can impact the resultant fiber strength.To identify any flaws that will not withstand the minimum stress expectations, all fiber material is subjected to an in-process stress test when produced by the vendor to develop a level of assurance that the fiber material can withstand a minimum amount of stress regardless of any flaws.When packaged, the fiber assemblies are coiled to a specific diameter to ensure any stress due to the coiled configuration is not excessive and should not adversely affect the strength of the fiber assembly for its labelled shelf life." the customer's reported complaint description of the fiber fractured/kinked is confirmed.A definitive root cause for the fiber fracture could not be determined, however, no manufacturing non-conformance was observed during sample evaluation.Fiber cores may have flaws but this is verified during manufacturing.A device history records search for the fiber kit revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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".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
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 12657982
• Report Number: 1319211-2021-00069
• Device Sequence Number: 20046588
• Product Code: GEX
• UDI-Device Identifier: H787EVLT55OPS5
• UDI-Public: H787EVLT55OPS5
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 01/31/2024
• Device Catalogue Number: EVLT55OPS
• Device Lot Number: 5660187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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
• Patient Sex: Unknown