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

Model Number	M006L8406931
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
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) 2022 that a flexiva pulse id laser fiber was used in a bladder stone procedure performed on (b)(6) 2022.The laser unit used was a lumenis 100 watt laser console.During preparation, the physician noticed that the laser fiber jacket cover extended to the very end of the laser fiber.The procedure was completed with another flexiva pulse id laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of fiber tip detached.Block h10: investigation results the returned flexiva pulse id laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The laser fiber measured 278.9 cm from the tip of the connector to the end of the exposed glass tip.The exposed glass was detached.A functional evaluation revealed that the light from the sma connector was bright and round, indicating that there was no fracture within the fiber connector.No other problems with the device were noted.The reported event of the flexiva pulse id laser fiber tip detached was confirmed.It is likely that procedural conditions and handling of the device during use contributed to the fiber tip damage.Therefore, the most probable root cause is adverse event related to procedure.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 instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a flexiva pulse id laser fiber was used in a bladder stone procedure performed on (b)(6) 2022.The laser unit used was a lumenis 100 watt laser console.During preparation, the physician noticed that the laser fiber jacket cover extended to the very end of the laser fiber.The procedure was completed with another flexiva pulse id laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA PULSE ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14147917
• Report Number: 3005099803-2022-02072
• Device Sequence Number: 16880333
• Product Code: GEX
• UDI-Device Identifier: 08714729978749
• UDI-Public: 08714729978749
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 10/20/2024
• Device Model Number: M006L8406931
• Device Catalogue Number: 2130-02
• Device Lot Number: 0028241074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown