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

Model Number	M006L8405911
Medical Device Problem Codes	Break (1069); Overheating of Device (1437); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
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 procedure to treat stones in the kidney and ureter, performed on (b)(6) 2022.The laser unit used was an moses laser console.During the procedure, the laser fiber connected to the laser console, a smoke was noticed at the connector.Upon examination, the laser fiber was broken on the body and tip.There was no burn injury to the user or to the patient and there were no fiber fragments fell inside the patient's body.The procedure was completed with another flexiva pulse laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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.
Additional Manufacturer Narrative
Upon receipt, this product was thoroughly analyzed in our quality assurance laboratory.Visual analysis of the returned fiber confirmed the reported smoke produced by the fiber event as analysis identified a fracture within the connector.During functional testing, there was no light present from the sub miniature a (sma) connector, indicating a fracture within the connector.The fiber connector may have a developed a microfracture that with use or handling can become larger resulting in an insufficient aiming beam and low laser energy output and ultimately can lead the connector to become overheated.According to the device instructions for use.Do not bend fiber at sharp angles.Visible light seen leaking from the fiber indicates fiber damage.
Event or Problem Description
It was reported to boston scientific corporation on march 21, 2022 that a flexiva pulse laser fiber was used during a ureteroscopy procedure to treat stones in the kidney and ureter, performed on (b(6) 2022.The laser unit used was an moses laser console.During the procedure, the laser fiber connected to the laser console, a smoke was noticed at the connector.Upon examination, the laser fiber was broken on the body and tip.There was no burn injury to the user or to the patient and there were no fiber fragments fell inside the patient's body.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 ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14136072
• Report Number: 3005099803-2022-01966
• Device Sequence Number: 3985907
• Product Code: GEX
• UDI-Device Identifier: 08714729978626
• UDI-Public: 08714729978626
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 05/31/2024
• Device Model Number: M006L8405911
• Device Catalogue Number: 2130-01
• Device Lot Number: 0027419263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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