MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063902010

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2021

Event Type  Other  

Event Description

While surgeon removing device from patient the device broke inside of the patient¿s urethra and was removed by the surgeon.All pieces were obtained.

• Brand Name: ESCAPE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 16673273
• MDR Text Key: 312630826
• Report Number: 16673273
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2023,08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: M0063902010
• Device Lot Number: 27542688
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1