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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC ZERO TIP BASKET RETRIEVAL

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BOSTON SCIENTIFIC BOSTON SCIENTIFIC ZERO TIP BASKET RETRIEVAL Back to Search Results
Model Number 0874729469643
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2017
Event Type  Injury  
Event Description
Basket split in half after being lasered.
 
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Brand NameBOSTON SCIENTIFIC ZERO TIP BASKET RETRIEVAL
Type of DeviceZERO TIP BASKET RETRIEVAL
Manufacturer (Section D)
BOSTON SCIENTIFIC
spencer IN 47460
MDR Report Key6273684
MDR Text Key65736204
Report NumberMW5067402
Device Sequence Number1
Product Code FFL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2018
Device Model Number0874729469643
Device Catalogue NumberM0063901050
Device Lot Number19981218
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/23/2017 Patient Sequence Number: 1
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