MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 3.8 MM X 403 MM ULTRASOUND PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number M0068407170

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

Mfg site name- electro medical systems.The device has been received for analysis.Upon 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.

Event Description

It was reported to boston scientific corporation an ultrasound probe was used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2018.According to the complainant, the ultrasound probe broke in half, inside the patient, at the close of the procedure.The broken pieces were retrieved using a pair of graspers.The procedure was successfully completed using this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Visual analysis of the returned lithoclast ultrasound probe revealed that the device was broken about 5 cm from the head.Scratches and traces of friction were observed.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A labeling review was performed and no anomalies were found.

Event Description

It was reported to boston scientific corporation an ultrasound probe was used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2018.According to the complainant, the ultrasound probe broke in half, inside the patient, at the close of the procedure.The broken pieces were retrieved using a pair of graspers.The procedure was successfully completed using this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: 3.8 MM X 403 MM ULTRASOUND PROBE
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7426137
• MDR Text Key: 105312849
• Report Number: 3005099803-2018-01151
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• Combination Product (y/n): N
• PMA/PMN Number: K012445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2020
• Device Model Number: M0068407170
• Device Catalogue Number: 840-717
• Device Lot Number: 0021322360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other