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	08/08/2018
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
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva 1000 laser fiber was used during a lithotripsy procedure in the bladder performed on (b)(6) 2018.Reportedly, the laser unit used was a lumenis 100 watt console.According to the complainant, during the procedure, the physician noted that the fiber tip detached after two minutes of use.Reportedly, no fiber fragments fell inside the patient.The procedure was completed with a non-bsc laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva 1000 laser fiber was used during a lithotripsy procedure in the bladder performed on (b)(6) 2018.Reportedly, the laser unit used was a lumenis 100 watt console.According to the complainant, during the procedure, the physician noted that the fiber tip detached after two minutes of use.Reportedly, no fiber fragments fell inside the patient.The procedure was completed with a non-bsc laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).Visual examination revealed that there was approximately 0.5 mm of 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 broke off.The condition of the returned device confirmed the event.Therefore, a 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 device history record (dhr) was performed and no deviations were found.

• 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: 7842880
• Report Number: 3005099803-2018-60239
• Device Sequence Number: 1981513
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/28/2018

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: 06/08/2021
• Device Model Number: M0068403940
• Device Catalogue Number: 69145
• Device Lot Number: 0000006151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1