MAUDE Adverse Event Report: ANGIODYNAMICS, INC OPS FIBER 80CM SPOTLIGHT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	H787EVLT80OPS5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Reference complaint #: (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: during preparation for the evlt procedure, when the laser fiber was removed from the sterile packaging, it was noted the fiber was kinked/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.The disposable device has been returned to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an 80 ops laser fiber.A visual inspection noted that there were 2 fractures of the fiber shaft, 69.6cm from the gripper and from the tip of the fiber, the fiber was broken 48.2cm.The fiber met all manufacturing dimensional specifications.The customer's reported complaint description of "broken fiber" is confirmed.A root cause for the complaint description cannot be definitively determined, however it does not appear to be manufacturing related.At the vendor facility, manufacturing and inspections procedures include a 100% inspection of the entire fiber, including the quality of each strip.Each unit is also repeatedly bent and coiled during the processing and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to packaging and shipment.During the hene laser test the fiber tip is examined closely for damage.During the packaging step, the fibers are inspected for damage.A review of the angiodynamics' 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.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 80CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7638946
• Report Number: 1319211-2018-00061
• Device Sequence Number: 1818446
• Product Code: GEX
• UDI-Device Identifier: H787EVLT80OPS5
• UDI-Public: H787EVLT80OPS5
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K041957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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 Expiration Date: 09/30/2019
• Device Catalogue Number: H787EVLT80OPS5
• Device Lot Number: 5089076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR