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

Catalog Number	H787EVLT55OPS5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
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: during preparation for the procedure, when the laser fiber was tested, the fiber appeared to be bent and energy was coming out of the side of the laser fiber shaft.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 evlt fiber and sheath.The fiber tip appeared to have a burn mark and the sheath's tip was missing.The customer's reported complaint of fiber was bent and energy appeared to come out of the side of the fiber was not confirmed.The product returned was noted of the following defects: the returned fiber (55cm ops) was noted to have a burn mark at the tip of the fiber.The returned sheath (80cm ops) was noted to have 22.7cm section missing of the distal end of the catheter sheath, it was noted the distal end was melted.Per the manufacturing engineer for this product: the returned fiber sample is a 55cm and the returned sheath was from an 80cm fiber kit.((b)(4) complaint is for a fractured fiber and is an 80cm fiber kit).A potential root cause of the sheath tip missing/melted and the fiber tip having burned residue was caused by the end user mismatching the kits, using the sheath from (80cm) (b)(4) and using a 55cm fiber.Per the engineer "i believe the end user replaced the broken fiber (from (b)(4)) with a 55cm fiber kit and left the initial 80cm distance catheter in the patient.This mismatch of the different sized components resulted in the tip of the 55cm ops fiber being positioned inside the 80cm catheter when the laser was activated it caused the catheter to melt approximately 22cm of the catheter.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 55CM SPOTLIGHT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 9174540
• Report Number: 1319211-2019-00097
• Device Sequence Number: 14363265
• Product Code: GEX
• UDI-Device Identifier: H787EVLT55OPS5
• UDI-Public: H787EVLT55OPS5
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 06/30/2022
• Device Catalogue Number: H787EVLT55OPS5
• Device Lot Number: 5485888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR