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

Model Number	2130-01
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	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation result: the returned flexiva pulse laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The laser fiber piece measured 278.3 cm from the tip of the connector to the end of the exposed glass tip.The exposed glass tip measured 3 mm and had normal degradation.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 laser fiber tip detached was not confirmed.As per the product analysis during the visual inspection the glass tip had normal degradation because the device was still used to complete the procedure, any signs of the tip being broken off could not be confirmed.Based on all gathered information and the results of the product analysis, the most probable root cause no problem detected.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 laser fiber was used during a ureteroscopy with laser lithotripsy procedure to treat ureteral stones in the ureter, performed on (b)(6) 2022.The laser unit used was a holmium lumenis 100 watt laser console.During the procedure, the tip of the laser fiber broke off inside the patient.The physician was unable to retrieve the fragment with a basket and though it would pass out naturally.The procedure was completed with another flexiva pulse laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA PULSE
• 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14701905
• Report Number: 3005099803-2022-03181
• Device Sequence Number: 5414990
• Product Code: GEX
• UDI-Device Identifier: 08714729978633
• UDI-Public: 08714729978633
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2024
• Device Model Number: 2130-01
• Device Catalogue Number: 2130-01
• Device Lot Number: 0028192744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female