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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC CORPORATION ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number GTIN
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/12/2021
Event Type  Injury  
Event Description
Stone basket broke leaving a portion of the device in the bladder. Surgeon was able to remove via cystoscopy.
 
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Brand NameZERO TIP NITINOL STONE RETRIEVAL BASKET
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key12195891
MDR Text Key262634134
Report NumberMW5102623
Device Sequence Number1
Product Code FFL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGTIN
Device Catalogue NumberM0063901050
Device Lot Number26302431
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/19/2021 Patient Sequence Number: 1
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