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

Model Number	M0068407170
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Note: this report pertains to the second of two devices that were used in the same procedure.Refer to manufacturer report number mfr.Report # 3005099803-2021-01230 for the lithoclast ultrasound probe and mfr report for the lithoclast ultrasound probe.It was reported to boston scientific corporation that two lithoclast ultrasound probes were used in a percutaneous nephrolithotomy procedure in the kidney performed on (b)(6) 2021.During the procedure, the ultrasound probes broke near the connection site.The physician noted that the handpiece was hot and the handpiece was transferring heat to the probe at the connection site, potentially making the probes weaker and contributing to their break.It was reported 350 millimeters of the probe detached inside the patient.The fragments were removed using reusable graspers.A third lithoclast probe was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional 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.
Event or Problem Description
Note: this report pertains to the second of two devices that were used in the same procedure.Refer to manufacturer report number mfr.Report # 3005099803-2021-01230 for the lithoclast ultrasound probe and mfr report #3005099803-2021-01231 for the lithoclast ultrasound probe.It was reported to boston scientific corporation that two lithoclast ultrasound probes were used in a percutaneous nephrolithotomy procedure in the kidney performed on (b)(6) 2021.During the procedure, the ultrasound probes broke near the connection site.The physician noted that the handpiece was hot and the handpiece was transferring heat to the probe at the connection site, potentially making the probes weaker and contributing to their break.It was reported 350 millimeters of the probe detached inside the patient.The fragments were removed using reusable graspers.A third lithoclast probe was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on april 1, 2021.During the procedure, the two ultrasound probes broke near the connection site and the handpiece was hot.The physician noted that the handpiece was hot and the handpiece was transferring heat to the probe at the connection site, potentially making the probes weaker and contributing to their break.The probes broke at their proximal end near the junction with the handpiece (and near the proximal end of the nephoscope).The piece that broke off of each 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.

• 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: 11601682
• Report Number: 3005099803-2021-01231
• Device Sequence Number: 4205865
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: M0068407170
• Device Catalogue Number: 840-717
• Device Lot Number: 0026111621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1