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

Catalog Number EVLT55OPS

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.Although no sample was returned for evaluation, a photo was provided by the customer which shows the fiber was fractured and detached.The picture only shows part of the fiber near the site mark and part of the fiber is no longer attached.The buffer is somewhat stretched at the break point and typically when a low stress fracture occurs while a fiber is still in the packaging, the glass core fractures but the buffer remains intact and holds the fiber together at the break point.The customer's reported complaint description of the fiber was fractured and detached was confirmed based on the picture provided by the end user, however, no complaint sample was returned.Although confirmed, a definitive root cause for the fiber fracture could not be determined without receiving the sample for evaluation.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".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).

Event Description

An end user experienced an issue when using a fiber from a evlt kit with spotlight ops sheath 55cm kit.When they opened the package, it was noticed the fiber was defective (fractured).A new of the same kit was opened and the procedure was completed.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

• Brand Name: OPS FIBER 55CM 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 ; 5086587990
• MDR Report Key: 16654894
• MDR Text Key: 312506132
• Report Number: 1319211-2023-00018
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787EVLT55OPS5
• UDI-Public: H787EVLT55OPS5
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/31/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: EVLT55OPS
• Device Lot Number: 5754655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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