MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number M0068407170

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  Injury  

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 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
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ELECTRO MEDICAL SYSTEMS SA; ch. de la vuarpilliere 31; ch-1260; nyon, sz 1260 ; CH 1260
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8545266
• MDR Text Key: 142934767
• Report Number: 3005099803-2019-02179
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR