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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD / C. R. BARD, INC. BARD PLATINUM CLASS II FLAT WIRE STONE BASKET / DISLODGER, STONE, BASKET, URETERAL

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BARD / C. R. BARD, INC. BARD PLATINUM CLASS II FLAT WIRE STONE BASKET / DISLODGER, STONE, BASKET, URETERAL Back to Search Results
Model Number 045370
Device Problems Sticking (1597); Difficult to Open or Close (2921)
Patient Problem No Code Available (3191)
Event Date 04/22/2018
Event Type  Injury  
Event Description
Pt underwent ureteroscopy with stone extraction procedure. The md used a basket to retrieve the stone. The operating room tech could not close the basket around stating it was stuck. The md was able to remove the basket, but the ureter was damaged in the process.
 
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Brand NameBARD PLATINUM CLASS II
Type of DeviceFLAT WIRE STONE BASKET / DISLODGER, STONE, BASKET, URETERAL
Manufacturer (Section D)
BARD / C. R. BARD, INC.
covington GA
MDR Report Key7463900
MDR Text Key106784737
Report NumberMW5076735
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number045370
Device Catalogue Number045370
Device Lot NumberBMAWMM12
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/25/2018 Patient Sequence Number: 1
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