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

Model Number 840-717

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

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 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) 2021.During the procedure, the physician noted the handpiece was hot as well as the at the probe connection site.The ultrasound probe broke, 350 millimeters detached inside the patient.The fragments were removed using reusable graspers.A new lithoclast probe was used to complete the procedure.There were no patient complications as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.

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) 2021.During the procedure, the physician noted the handpiece was hot as well as the at the probe connection site.The ultrasound probe broke, 350 millimeters detached inside the patient.The fragments were removed using reusable graspers.A new lithoclast probe was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on april 1, 2021: during the procedure, the ultrasound probe broke near the connection site and the handpiece was hot.The probe broke at the proximal end near the junction with the handpiece (and near the proximal end of the nephoscope).The piece that broke off of the probe was approximately 35 cm long.It was reported that there was still plenty of length outside the patient for the physician to grab and remove the entire length of the broken piece.A new lithoclast probe was used to complete the procedure.

Manufacturer Narrative

The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, an analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: ULTRASOUND PROBE
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 11602015
• MDR Text Key: 243685952
• Report Number: 3005099803-2021-01248
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• Combination Product (y/n): N
• PMA/PMN Number: K012445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 840-717
• Device Catalogue Number: 840-717
• Device Lot Number: 0026111621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1