MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403931
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The fiber was returned broken into two pieces.The first piece measured approximately 105.6 cm from the top of the connector to the break.The second piece measured approximately 173.3 cm from the break to the tip.The distal tip was noted as damaged.Examination under magnification reveals that the fiber tip measures approximately 3.5 mm.The pattern on the tip face is consistent with a tip detachment, likely as a result of handling during the procedure.The remainder of the fiber, was not returned.The condition of the returned device confirmed that the fiber was broken.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.A complaint with a cause of manufacturing deficiency indicates that the problems were traced to the manufacturing process.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.A search of the complaint database confirmed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva 550 laser fiber was opened for use for a flexible ureteroscopy procedure in the ureter performed on (b)(6) 2018.According to the complainant, during the procedure, the fiber was noted to be broken right out of the package.The procedure was completed with another flexiva 550 laser fiber.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation results; fiber tip detached.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8437177
• Report Number: 3005099803-2019-01373
• Device Sequence Number: 239313
• Product Code: GEX
• UDI-Device Identifier: 08714729808213
• UDI-Public: 08714729808213
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• 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
• Report Date (Section B): 03/20/2019

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: 02/09/2021
• Device Model Number: M0068403931
• Device Catalogue Number: 840-393
• Device Lot Number: 0000005633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1