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

Model Number M0068407170

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Mfg site name- electro medical systems.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

This manufacturer report pertains to one of three devices supposed to be used in the same procedure.Refer to the associated manufacturer report numbers 3005099803-2018-01255 and 3005099803-2018-01257 for the other associated device information.It was reported to boston scientific corporation on (b)(6) 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
• 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: 7447267
• MDR Text Key: 106144858
• Report Number: 3005099803-2018-01256
• 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: Physician
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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