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

Model Number M006L8406960

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2023

Event Type  Injury  

Event Description

During lithotripsy procedure, provider noted on monitor that the laser fiber had broken.Upon removal of the fiber from the scope, the broken fragment dropped into the patient's bladder and was removed as part of the planned procedure.Examination after removal of the known fragment revealed no other fragments.No suspected harm to the patient.

• Brand Name: FLEXIVA PULSE ID TRAC TIP LASER FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17109328
• MDR Text Key: 317126060
• Report Number: MW5118328
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006L8406960
• Device Catalogue Number: M006L8406960
• Device Lot Number: 30554511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White