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	08/07/2019
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 august 7, 2019 that a flexiva 1000 laser fiber used in a bladder stone procedure in the bladder performed on (b)(6) 2019.Reportedly, the laser unit used was a lumenis 100w console with high hertz settings.According to the complainant, during preparation, it was noted that the tip of the laser fiber was missing upon opening the package.There was 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 august 7, 2019 that a flexiva 1000 laser fiber used in a bladder stone procedure in the bladder performed on (b)(6) 2019.Reportedly, the laser unit used was a lumenis 100w console with high hertz settings.According to the complainant, during preparation, it was noted that the tip of the laser fiber was missing upon opening the package.There was no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 2907 captures the reportable event of fiber tip detached.Block h10: investigation results one flexiva 1000 laser fiber was returned in one piece.The pieced measured approximately 274.3 cm from the top of the connector to the tip.The fiber tip was detached back to the jacketing with no exposed glass remaining.Examination under magnification revealed that the fiber tip was fractured with a portion detached.The remainder of the tip was not returned.Review and analysis of all available information indicated that the cause code for this event 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 dhr (device history record) review was performed and the device met all manufacturing specifications.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

• 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: 8966639
• Report Number: 3005099803-2019-04443
• Device Sequence Number: 2041821
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/19/2019

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: 06/11/2022
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000007889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1