MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403940
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch number is mw5094766.(b)(4).The returned flexiva 1000 laser fiber was analyzed, and a visual evaluation noted that the fiber tip was detached.The fiber measured approximately 281.3 cm from the top of the connector to the broken tip.The exposed glass portion of the tip measured approximately 0.5 mm and appeared fractured.Examination under magnification confirmed that the pattern on the tip was consistent with a fracture.The remainder of the tip was not returned.No other issues with the device were noted.The reported event of fiber failed, was confirmed as fiber tip detached.The analysis of returned device found that the fiber tip was fractured, likely as a result of handling of the device as it was used and interacted with the scope.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
This report pertains to the second of two devices that were used in the same procedure.Refer to manufacturer report number mfr.Report # 3005099803-2020-02835 for the first flexiva 1000 laser fiber and mfr.Report # 3005099803-2020-03056 for the second flexiva 1000 laser fiber.A flexiva 1000 laser fiber was returned to boston scientific corporation.This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed and the tip was detached.It was confirmed on july 21, 2020 that this was device was used in a procedure on (b)(6) 2020.The flexiva 1000 laser fiber was used in a ureteroscopy with laser lithotripsy procedure in the ureter performed on (b)(6) 2020.Reportedly, the laser unit used was a lumenis 20 watt laser console.According to the complainant, during the procedure, the laser fiber broke.A second of the same device was opened and failed.The procedure was completed with a third flexiva 1000 laser fiber.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of tip detached.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10346120
• Report Number: 3005099803-2020-03056
• Device Sequence Number: 3293962
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 07/30/2020

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: 03/17/2023
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000009303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1