MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 3.8 MM X 403 MM ULTRASOUND PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number	M0068407170
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2018
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 manufacturer report pertains to one of three devices supposed to be used in the same procedure.Refer to the associated manufacturer report numbers 3005099803-2018-01256 and 3005099803-2018-01257 for the other associated device information.It was reported to boston scientific corporation on april 04, 2018 that three lithoclast ultrasound probes were opened to be used for a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the packaging including the sterile pouch was noted to be crumpled on all three lithoclast ultrasound probes.The plastic packaging was also bent up.The procedure was completed with another lithoclast ultrasound probe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: 3.8 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: 7447297
• Report Number: 3005099803-2018-01255
• Device Sequence Number: 1476706
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/04/2018

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: 11/13/2020
• Device Model Number: M0068407170
• Device Catalogue Number: 840-717
• Device Lot Number: 21383655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1