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	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the device evaluation will be sent via a follow up medwatch.Reference complaint #(b)(4).
Event or Problem Description
It was reported that during an evlt procedure, the laser fiber fractured inside of the patient.The fractured piece was successfully removed.The procedure was completed with a new of the same device.The patient suffered no harm or injury due to this event.It was reported the disposable device is not 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.As a device evaluation could not be performed, a root cause for the event cannot be determined.The customer's reported complaint of a fractured fiber could not be confirmed as the sample was not returned for evaluation.Without receiving product to evaluate, the root cause cannot be determined, although it is unlikely that the fiber was fractured prior to packaging.The most likely root cause to this event is due to handling after the device left the angiodynamics facility.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.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.During the packaging step, the fibers are inspected for damage.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).

• 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: 8286805
• Report Number: 1319211-2019-00006
• Device Sequence Number: 13941376
• Product Code: GEX
• UDI-Device Identifier: H787EVLT55OPS5
• UDI-Public: H787EVLT55OPS5
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K041957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: H787EVLT55OPS5
• Device Lot Number: 5396788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention