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

Model Number	M0068403921
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on april 11 2019 that a flexiva 365 laser fiber was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2019.According to the complainant, during the procedure, while they were advancing the laser fiber, it was broken 3-4 mm between the sma connector and the fiber body.The procedure was completed with another flexiva 365 laser fiber.There was no serious injury nor adverse patient effects reported as a result of this event.There were no patient complications.
Additional Manufacturer Narrative
Problem code 1069 captures the reportable event of fiber broke.Investigation results: one flexiva 365 laser fiber was returned broken in two pieces.The first piece measured approximately 130.9 cm from the top of the connector to the break.The second piece measured approximately 186.5 cm from the break and includes the entire distal tip.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared unused.Examination under magnification confirmed that the tip was unused.The condition of the returned device confirms 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 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 april 11 2019 that a flexiva 365 laser fiber was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2019.According to the complainant, during the procedure, while they were advancing the laser fiber, it was broken 3-4 mm between the sma connector and the fiber body.The procedure was completed with another flexiva 365 laser fiber.There was no serious injury nor adverse patient effects reported as a result of this event.There were no patient complications.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8570007
• Report Number: 3005099803-2019-02317
• Device Sequence Number: 1836307
• Product Code: GEX
• UDI-Device Identifier: 08714729808190
• UDI-Public: 08714729808190
• 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,Followup
• Report Date (Section B): 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: M0068403921
• Device Catalogue Number: 840-392
• Device Lot Number: 0000006001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1