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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ESCAPE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063902010
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an escape nitinol stone retrieval basket was used in the kidney and ureter during a retrograde intrarenal surgery (rirs) ureteroscopy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, a white string was found on the device and can be seen from the monitor. It was noted that the string affected the view. Additionally, it was reported that there was no damage noted on the device. The procedure was completed with this device. 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 stable.
 
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Brand NameESCAPE
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key10051780
MDR Text Key191735837
Report Number3005099803-2020-01875
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063902010
Device Catalogue Number390-201
Device Lot Number0025175617
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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