MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User facility/medwatch number: (b)(4).(b)(4).The device has not been received for analysis.Upon receipt and 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 that a lithoclast ultrasound probe was used during a percutaneous nephrolithotomy procedure in the kidney performed on (b)(6) 2019.According to the complainant, during the procedure, the ultrasound probe broke in half midway through the procedure and the broken piece was removed from the sterile field.The procedure was completed with another lithoclast ultrasound probe.There were no serious injury/adverse effect to patient as a result of the event.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: ULTRASOUND PROBE
• Common Device Name: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8545266
• Report Number: 3005099803-2019-02179
• Device Sequence Number: 2430973
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 12/02/2021
• Device Model Number: M0068407170
• Device Catalogue Number: 840-717
• Device Lot Number: 0023023809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR