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

Model Number	M006R8403940
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	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 as it was not indicated what was the specific date.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 march 11, 2020 that a flexiva id 1000 laser fiber was used in a bladder stone procedure in the bladder performed on an unknown date.Reportedly, the laser unit used was a p100 laser console with laser settings of 1.2 joules and 10 hertz.According to the complainant, during the procedure, the laser fiber tip broke off inside the patient upon laser activation.The procedure was completed with another flexiva id 1000 laser fiber.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2020 as it was not indicated what was the specific date.Block h6: problem code 2907 captures the reportable event of fiber tip detached.Block h10: investigation result: the returned flexiva id 1000 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured approximately 279.3 cm from the top of the connector to the tip.The exposed glass tip measured approximately 0.5 mm and appeared fractured.Examination under magnification confirmed the pattern on the tip was consistent with a fracture.It is likely that the handling of the device during setup caused damage to the fiber that manifested during the procedure.It is also likely that the tip could have become damaged as the fiber interacted with the scope.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device confirmed that the fiber tip was detached.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 march 11, 2020 that a flexiva id 1000 laser fiber was used in a bladder stone procedure in the bladder performed on an unknown date.Reportedly, the laser unit used was a p100 laser console with laser settings of 1.2 joules and 10 hertz.According to the complainant, during the procedure, the laser fiber tip broke off inside the patient upon laser activation.The procedure was completed with another flexiva id 1000 laser fiber.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9920352
• Report Number: 3005099803-2020-01439
• Device Sequence Number: 19651299
• Product Code: GEX
• UDI-Device Identifier: 08714729963813
• UDI-Public: 08714729963813
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 12/11/2022
• Device Model Number: M006R8403940
• Device Catalogue Number: 69269
• Device Lot Number: 0000008873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1