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

Model Number	2130-02
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination identified that the fiber body was broken as the length of the fiber is approximately 300cm and the length received was 194cm.When connected to the laser console, the following message was displayed: treatments used 0, treatments left 1.A review of the device history record confirmed that the fiber met all material, assembly and performance specifications prior to release.Based on the analysis results, it is likely that there was a fiber body break based on the length that was returned.The alleged distal tip frayed/melted event was not confirmed as the tip was not received for analysis according to the device instructions for use (ifu), carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket/fiber or other particulates/pieces, or other visual damage.If the fiber appears damaged, do not use the device.If it is an unused device, return it to boston scientific for replacement.
Event or Problem Description
It was reported that during a kidney procedure two different fibers failed as the distal tip frayed/melted.The procedure was completed with an alternative method with no patient complications.The fiber was returned, and analysis identified a fiber break.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination identified that the fiber body was broken as the length of the fiber is approximately 300cm and the length received was 194cm.When connected to the laser console, the following message was displayed: treatments used 0, treatments left 1.A review of the device history record confirmed that the fiber met all material, assembly and performance specifications prior to release.Based on the analysis results, it is likely that there was a fiber body break based on the length that was returned.The alleged distal tip frayed/melted event was not confirmed as the tip was not received for analysis according to the device instructions for use (ifu), carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket/fiber or other particulates/pieces, or other visual damage.If the fiber appears damaged, do not use the device.If it is an unused device, return it to boston scientific for replacement.
Event or Problem Description
It was reported that during a kidney procedure two different fibers failed as the distal tip frayed/melted.The procedure was completed with an alternative method with no patient complications.

• 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 MA 14110 ; MY 14110
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17686515
• Report Number: 2124215-2023-46611
• Device Sequence Number: 2598710
• Product Code: GEX
• UDI-Device Identifier: 08714729978718
• UDI-Public: 08714729978718
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 09/04/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030082830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown