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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. DIMENSION DISLODGER, STONE, BASKET, URETERAL, METAL

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C. R. BARD, INC. DIMENSION DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number 042313
Device Problem Material Fragmentation (1261)
Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)
Event Date 12/14/2016
Event Type  malfunction  
Event Description
Patient for removal of calculus in right kidney. During procedure, a dimension basket was used to retrieve stone fragments. Due to considerable difficulty in distal right ureter in removing basket with gentle pressure, the basket was cut and it was left in place. A semi-rigid ureteroscope was inserted and gentle traction resulted in the basket fracture and it remained intraureteral. Fragments of basket were retrieved; tongs of basket remained. Various other maneuvers attempted to retrieve tongs of basket but were unsuccessful. Due to poor visualization from the ureteral manipulation and trauma and increased bleeding and edema, it was determined to be no longer safe and decision was made to abort procedure and place a stent. Fragments of stone and tongs of basket remained in patient's ureter. Stent to remain in place for passive dilation with plan to bring patient back to operating room in near future for retrieval of additional stone fragments and additional iatrogenic fragments of basket. Patient returned to operating room for cystoscopy, ureteroscopy with lithotripsy, basket stone extraction and insertion of ureteral right stent due to calculus of right kidney. Retained foreign body was successfully retrieved and removed from patient. Peer review conducted and concluded that it is unclear why basket broke during first procedure; basket sent back to manufacturer for further evaluation.
 
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Brand NameDIMENSION
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
C. R. BARD, INC.
8195 industrial blvd.
covington GA 30014
MDR Report Key6278910
MDR Text Key65791895
Report Number6278910
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 User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model Number042313
Device Catalogue Number042313
Device Lot NumberBMZLM028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/13/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/13/2017
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: 01/26/2017 Patient Sequence Number: 1
Treatment
NO
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