MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 3.3 MM X 403 MM ULTRASOUND PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number	M0068407160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to the associated manufacturer report 3005099803-2017-03909 for the other associated device information.It was reported to boston scientific corporation on (b)(6) 2017 that two ultrasound probes were used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, ten minutes into the procedure, the first ultrasound probe (the subject of this mfr report) broke in half when the lithoclast was at level 90.The same issue happened with the second ultrasound probe (mfr report #3005099803-2017-03909).The broken pieces were retrieved from inside the patient with the use of a grasper.The procedure was successfully completed using another of the same device and also a holmium laser.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 good.

• Brand Name: 3.3 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: 7148066
• Report Number: 3005099803-2017-03908
• Device Sequence Number: 11105704
• Product Code: FFK
• UDI-Device Identifier: 08714729516606
• UDI-Public: 08714729516606
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 12/07/2017

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: 09/27/2020
• Device Model Number: M0068407160
• Device Catalogue Number: 840-716
• Device Lot Number: 21188293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/27/2017
• 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