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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. UNIVERSA SOFT URETERAL STENT SET ; STENT, URETERAL
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COOK, INC. UNIVERSA SOFT URETERAL STENT SET ; STENT, URETERAL Back to Search Results
Catalog Number USH-726-R
Device Problem Material Separation (1562)
Patient Problem Foreign body, removal of (2365)
Event Date 10/24/2014
Event Type  Injury  
Event Description
The initial stent placement was on (b)(6) 2014, due to right antegrade nephrostogram.Upon stent exchange on (b)(6) 2014, the surgeon went to remove the stent and as it exited the urethra, the physician became aware that it had broken at the distal end, and that there was stent collected in the bladder.It was found that the stent fractured in two places.Upon noticing that the stent had fragmented, the surgeon went back in through the cystoscope and collected the remaining stent fragments.All fragments were successfully removed.The pt did not require any add'l procedures nor experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
(b)(4).Event is still under investigation.
 
Manufacturer Narrative
(b)(4).The visual examination confirmed that the stent separated in the location of a sideport.Quality control specification assures proper position, sideport walls, shape and appearance additionally, sideport quality control personnel assures sideports are clean and uniform in appearance and are not jagged or rough.Appropriate controls are in place to detect a potential weak point in the stent due to a sideport.Based on the info provided and the results of our investigation, a root cause for the failure cannot be determined with certainty at this time.However, it is possible the catheter separated at the location of a sideport after potentially being pulled with too much force.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), no further action is required.
 
Event Description
The initial stent placement was on (b)(6) 2014, due to right antegrade nephrostogram.Upon stent exchange on (b)(6) 2014, the surgeon went to remove the stent and as it exited the urethra, the physician became aware that it had broken at the distal end, and that there was stent collected in the bladder.It was found that the stent fractured in two places.Upon noticing that the stent had fragmented, the surgeon went back in through the cystoscope and collected the remaining stent fragments.All fragments were successfully removed.The pt did not require any add'l procedures nor experience any adverse effects due to this occurrence.
 
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Brand Name
UNIVERSA SOFT URETERAL STENT SET
Type of Device
STENT, URETERAL
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key4257529
MDR Text Key18087089
Report Number1820334-2014-00599
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/27/2014
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 Expiration Date05/01/2015
Device Catalogue NumberUSH-726-R
Device Lot NumberU2209846
Other Device ID Number(01)10827002499826(17)150501(1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/04/2014
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/24/2014
Device Age18 MO
Event Location Hospital
Initial Date Manufacturer Received 10/29/2014
Initial Date FDA Received11/05/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age7 YR
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