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

Model Number	M006R8403941
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	07/06/2018
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
Note: this manufacturer report pertains to one of three devices used in the same procedure.Refer to the associated manufacturer report numbers 3005099803-2018-02420 and 3005099803-2018-02421 for the referenced device information.It was reported to boston scientific corporation on (b)(6) 2018 that three flexiva id 1000 laser fibers were used during a procedure in the kidney and bladder performed on (b)(6) 2018.Reportedly, the laser unit used was a lumenis p120 with moses console.According to the complainant, during the procedure and inside the patient, the tip of the laser fibers detached after 1 to 2 minutes of use.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.
Event or Problem Description
Note: this manufacturer report pertains to one of three devices used in the same procedure.Refer to the associated manufacturer report numbers 3005099803-2018-02420 and 3005099803-2018-02421 for the referenced device information.It was reported to boston scientific corporation on (b)(6) 2018 that three flexiva id 1000 laser fibers were used during a procedure in the kidney and bladder performed on (b)(6) 2018.Reportedly, the laser unit used was a lumenis p120 with moses console.According to the complainant, during the procedure and inside the patient, the tip of the laser fibers detached after 1 to 2 minutes of use.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.
Additional Manufacturer Narrative
Investigation results.One flexiva id 1000 laser fiber was received for evaluation.Visual examination revealed that there was no exposed glass fiber tip remaining.Additional examination under magnification revealed that the pattern on the tip face was consistent with a fracture indicating that the tip or portion of the tip detached.There was no damage along the body of the fiber.The condition of the returned device confirms the event.The noted damages indicate difficulty was experienced during the procedure and was likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.

• Brand Name: FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7722576
• Report Number: 3005099803-2018-02422
• Device Sequence Number: 13715737
• Product Code: GEX
• UDI-Device Identifier: 08714729963820
• UDI-Public: 08714729963820
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/06/2018

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: 03/02/2021
• Device Model Number: M006R8403941
• Device Lot Number: 0000005728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1