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

Model Number	M0068403940
Medical Device Problem Code	Break (1069)
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).Investigation results: the returned flexiva 1000 laser fiber was analyzed, and a visual evaluation noted that it was returned with the body broken.The fiber measured 274.4 cm in length from the top of the connector to the break.Examination under magnification confirmed that the pattern on the break was consistent with a fracture.The remainder of the device was not returned.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device confirmed that the fiber was broken.The condition of the returned device confirms that the fiber was broken during use, 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 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
It was reported to boston scientific corporation on (b)(6) 2020 that a 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.The procedure was completed with another flexiva 1000 laser fiber.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to the first 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.It was reported to boston scientific corporation on (b)(6), 2020 that a 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.The procedure was completed with another flexiva 1000 laser fiber.There were no patient complications reported as a result of this event.** additional information received on (b)(6), 2020 ** 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.
Additional Manufacturer Narrative
Block h2: additional information: block b5 block g3: medwatch number is mw5094766.Block h6: problem code 1069 captures the reportable event of fiber break.Block h10: investigation results the returned flexiva 1000 laser fiber was analyzed, and a visual evaluation noted that it was returned with the body broken.The fiber measured 274.4 cm in length from the top of the connector to the break.Examination under magnification confirmed that the pattern on the break was consistent with a fracture.The remainder of the device was not returned.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device confirmed that the fiber was broken.The condition of the returned device confirms that the fiber was broken during use, 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 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.

• 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: 10285560
• Report Number: 3005099803-2020-02835
• Device Sequence Number: 2780145
• 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,Followup
• Report Date (Section B): 08/07/2020

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
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1