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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; NONE
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COOK INC UNIVERSA FIRM URETERAL STENT SET; NONE Back to Search Results
Model Number N/A
Device Problems Malfunction (2409); Appropriate Term/Code Not Available (3191)
Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)
Event Type  Injury  
Event Description
After inserting a stent, the pt suffered from hydronephrosis when the kidney did not drain as expected.Pt outcome has been requested but not provided.
 
Manufacturer Narrative
(b)(4).The event is currently under investigation.
 
Manufacturer Narrative
Date of event was not provided by the reporter.Common name is unknown as not lot # was provided.Lot # is unknown as it was not provided.Catalog # is unknown as it was not provided.(universa firm ureteral stent set) udi# is unknown as no lot # was provided.User facility date of awareness is unknown as it was not provided.Device age is unknown as no lot # was provided.(b)(4).
 
Event Description
After inserting a stent, the patient suffered from hydronephrosis when the kidney did not drain as expected.Patient outcome has been requested but not provided.
 
Manufacturer Narrative
Date of event was not provided by the reporter.Common name is unknown as not lot # was provided.Lot # is unknown as it was not provided.Catalog # is unknown as it was not provided.(universa firm ureteral stent set) udi# is unknown as no lot # was provided.User facility date of awareness is unknown as it was not provided.Device age is unknown as no lot # was provided.(b)(4).Investigation - evaluation: a review of complaint history, instructions for use (ifu), quality control, specifications, trends, and a visual inspection of the returned device and inspection of unused products were conducted during the investigation.Product was returned for evaluation.Stent was wired with a 0.038" wireguide to ensure patency.It is possible that stent may have kinked during use, preventing drainage.Stent was wired with a.038" wireguide.Failure mode could not be replicated bench-top.It is possible the stent may have become occluded during use due to a kink in the material.The root cause is determined to be due to product use during the procedure.There is no evidence to suggest items in this lot were not manufactured in accordance to the current specification.The instructions for use (ifu) for the product states "complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures." the appropriate internal personnel have been notified of the case, and we will continue to monitor for similar complaints.
 
Event Description
After inserting a stent, the patient suffered from hydronephrosis when the kidney did not drain as expected.Patient outcome has been requested but not provided.
 
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Brand Name
UNIVERSA FIRM URETERAL STENT SET
Type of Device
NONE
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key4665107
MDR Text Key5603976
Report Number1820334-2015-00175
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor,distributor,forei
Reporter Occupation Physician
Type of Report Initial
Report Date 03/03/2015
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 NumberN/A
Device Catalogue NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Initial Date Manufacturer Received 03/05/2015
Initial Date FDA Received04/02/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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