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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL URETERAL STENT; STENT URETH FIRM
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COOK MEDICAL URETERAL STENT; STENT URETH FIRM Back to Search Results
Model Number 5FRX11 - 32CM
Device Problems Use of Device Problem (1670); Malposition of Device (2616); Device Operational Issue (2914)
Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Injury (2348)
Event Date 02/15/2018
Event Type  Injury  
Event Description
Malpositioned ureteral stent.Pt had undergone a left psoas hitch and an attempt left ureteral implant secondary to a very difficult exposure.It appears as that the stent for the ureteral psoas hitch had been placed into the gonadal vein, and positioned through the left renal vein, and into the vena cava with a coil most likely in the bladder.
 
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Brand Name
URETERAL STENT
Type of Device
STENT URETH FIRM
Manufacturer (Section D)
COOK MEDICAL
750 daniels way
bloomington IN 47404
MDR Report Key7323027
MDR Text Key101988950
Report Number7323027
Device Sequence Number1
Product Code FAD
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 02/25/2018,02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number5FRX11 - 32CM
Device Lot Number639144
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/28/2018
Distributor Facility Aware Date02/18/2018
Event Location Hospital
Date Report to Manufacturer02/28/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/02/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age46 YR
Patient Weight118
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