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

Catalog Number	H787EVLT55OPS5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: during preparation for the procedure, when the laser fiber was removed from the sterile packaging, it was noted the tip of the fiber was fractured.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient due to the event as the device did not come into contact with the patient.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of the fiber tip was fractured cannot be determined due to product not being returned.As a device evaluation was not performed, a definitive root cause for the reported complaint description cannot be determined.However, it does not appear to be manufacturing related.A review of the lot history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lots 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 manufacturing process, the disposable fiber device receives two 100% inspections and one aql inspection in which the power output verified using a diode laser and power meter prior to packaging.The fiber must is attached and detached from a laser unit during these inspections.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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference complaint #(b)(4).
Additional Manufacturer Narrative
Returned for evaluation was an evlt 55 ops fiber.A visual inspection noted that 1.8cm from the tip, the fiber is fractured.The customer's reported complaint description of the fiber tip was fractured was confirmed.The patient was unaffected due to this event.Evaluation of the fiber did not reveal any manufacturing non-conformances with the device.A review of the lot history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lots 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 manufacturing process, the disposable fiber device receives two 100% inspections and one aql inspection in which the power output verified using a diode laser and power meter prior to packaging.The fiber must is attached and detached from a laser unit during these inspections.Althought the complaint is confirmed, a definitive root cause for the defect cannot be determined.It does not appear to be manufacturing related, and is most likely handling damage after the fiber left the manufacturing facility.The instructions 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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference complaint # (b)(4).

• Brand Name: OPS FIBER 55CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7506213
• Report Number: 1319211-2018-00047
• Device Sequence Number: 13877258
• Product Code: GEX
• UDI-Device Identifier: H787EVLT55OPS5
• UDI-Public: H787EVLT55OPS5
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2018

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: Physician
• Device Catalogue Number: H787EVLT55OPS5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018; 04/19/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 08/31/2018; 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1