MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBES; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number M0068407170

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

Two boston scientific ultrasound probes broke in half while being used during a left percutaneous nephrolithotomy procedure.Both broke at the end that was outside the patient.Both halves were retrieved for both probes.A third probe was opened, and procedure was completed.Fda safety report id # (b)(4).

• Brand Name: ULTRASOUND PROBES
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12325151
• MDR Text Key: 267033881
• Report Number: MW5103264
• Device Sequence Number: 2
• Product Code: FFK
• 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: 08/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M0068407170
• Device Catalogue Number: M0068407170 (840-717)
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1