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	12/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mfg site name- (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 on (b)(6) 2017 that an ultrasound probe was used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the ultrasound probe broke about 4cm from the proximal end.Half of the broken piece fell inside the patient and was retrieved with the use of forceps.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• 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: 7193258
• Report Number: 3005099803-2018-00093
• Device Sequence Number: 11250769
• Product Code: FFK
• UDI-Device Identifier: 08714729516606
• UDI-Public: 08714729516606
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/28/2017

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: 11/12/2020
• Device Model Number: M0068407160
• Device Catalogue Number: 840-716
• Device Lot Number: 21380570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/16/2018
• 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