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

Model Number	M0068407170
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7426137
• Report Number: 3005099803-2018-01151
• Device Sequence Number: 148224
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K012445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other