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

Model Number	M006L8406931
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that flexiva pulse id laser fibers have been used during ureteroscopy procedures to treat stones in the kidney.During the procedure, the laser fibers were found to be defective.The procedure was not completed due to the event.There were no patient complications reported as a result of this event.Despite good faith efforts, no information has been received to date to clarify the number of fibers that were defective, the nature of the defects and the date or dates the events occurred.
Additional Manufacturer Narrative
Block b3, date of event: approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.Block h2: additional information: blocks b5, d4 (lot number and expiration date), e1 (initial reporter information), and h4 (manufactured date) have been updated.Block h6 (conclusion codes): evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on march 1, 2022 that flexiva pulse id laser fibers have been used during ureteroscopy procedures to treat stones in the kidney.During the procedure, the laser fibers were found to be defective.The procedure was not completed due to the event.There were no patient complications reported as a result of this event.Additional information received on march 30, 2022: the procedure was successfully completed with another flexiva pulse id laser fiber.

• 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: 13895732
• Report Number: 3005099803-2022-01639
• Device Sequence Number: 4065629
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 09/14/2024
• Device Model Number: M006L8406931
• Device Catalogue Number: 2130-02
• Device Lot Number: 0028022568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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