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	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 (b)(6), 2020 that a flexiva id 1000 laser fiber was used in a bladder stone procedure in the bladder performed on (b)(6), 2020.According to the complainant, during the procedure, the tip of the laser fiber blew up after a minute of use.Reportedly, there was no injury to the patient or user.The procedure was completed with another flexiva id 1000 laser fiber.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation on march 13, 2020 that a flexiva id 1000 laser fiber was used in a bladder stone procedure in the bladder performed on (b)(6) 2020.According to the complainant, during the procedure, the tip of the laser fiber blew up after a minute of use.Reportedly, there was no injury to the patient or user.The procedure was completed with another flexiva id 1000 laser fiber.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: problem code 2907 captures the reportable event of fiber tip detached.Block h10: investigation results: 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 279.5 cm from the top of the connector to the tip.The tip was fractured back to the jacketing and no exposed glass remained.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 product labeling review identified that the device was used per the directions for use (dfu) / product label.

• 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: 9917094
• Report Number: 3005099803-2020-01466
• Device Sequence Number: 2814518
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 03/27/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1