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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. C-FLEX; STENT, URETERAL
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COOK, INC. C-FLEX; STENT, URETERAL Back to Search Results
Catalog Number G14799
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/27/2016
Event Type  malfunction  
Event Description
A (b)(6) patient who had a stent placed in mid (b)(6) was found to be having issues that required removal of the stent in late (b)(6) and subsequently an interventional radiology procedure at the end of (b)(6) to retrieve additional fractured pieces.The stent broke when attempting to remove it and additionally fractured further after removal and examination in the sterile field.Unfortunately risk was not made aware of this incident until today and investigation determined that it was sent back to the manufacturer but our supply chain medsun rep was not notified.I further investigated and unfortunately none of the pieces from the ir retrieval procedure were retained.
 
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Brand Name
C-FLEX
Type of Device
STENT, URETERAL
Manufacturer (Section D)
COOK, INC.
750 daniels way
bloomington IN 47404
MDR Report Key6099469
MDR Text Key59772149
Report Number6099469
Device Sequence Number1
Product Code GBL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberG14799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/07/2016
Event Location Hospital
Date Report to Manufacturer09/07/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age7 YR
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