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	07/08/2019
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
A male patient of unknown age presented for an evlt procedure using a 55ops fiber kit.The treating physician reported the wire (cheater?) broke off into the sheath during use.The device was removed as a unit, set aside and a new of the same device was used to complete the case.The patient suffered no harm or injury due to this event as the fragment was retained inside of the sheath.The disposable device has been returned to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Based on sample evaluation this event is not an unraveled guidewire as originally reported, it is a broken j straightener.This is not a reportable event.This supplemental mdr is being submitted in order to close the complaint record.Returned for evaluation was a guidewire still in the protective hoop.It was noted the distal end of the hoop had the "j" tip advanced inside the hoop.Also returned was a dilator sheath containing the "j" straightener of the guidewire.The device was forwarded to angiodynamics' supplier of this product.Per the supplier's device evaluation, "at the fractured there is no indication that there was a material defect in the insertion aid." the customer's reported complaint description of a wire (cheater) broke off into the sheath during use is confirmed.The returned sample noted the "j" straightener was indeed in the hub of the sheath and the remainder of the straightener was in the guidewire tube.Although the complaint description is confirmed a root cause cannot be determined.A potential root cause for the damage could be from handling by the end user.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.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: 8866384
• Report Number: 1319211-2019-00070
• Device Sequence Number: 2754698
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 05/31/2022
• Device Catalogue Number: H787EVLT55OPS5
• Device Lot Number: 5470527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1