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

Model Number M0068407160

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

Event Type  Injury  

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 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
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7193258
• MDR Text Key: 97326027
• Report Number: 3005099803-2018-00093
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 08714729516606
• UDI-Public: 08714729516606
• 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: Physician
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other