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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET
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COOK IRELAND LTD RESONANCE STENT SET Back to Search Results
Catalog Number RMS-060020-R
Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 12/16/2020
Event Type  Injury  
Manufacturer Narrative
Fad stent, ureteral.(b)(4).
 
Event Description
A resonance stent was placed in (b)(6) 2019 and scheduled for a routine stent exchange today, (b)(6) 2020.The district manager advised the user facility that this is past the recommended indwelling time.During removal of the stent, it was noted that the distal end of the stent was no longer in the bladder and had migrated into the ureter.An attempt was made to remove the stent with graspers, was noted to have ingrown into the mucosa of the ureter.A laser was used around the ingrown portion.During use of the laser, a piece of the stent broke off and was retrieved with graspers from the patient.The doctor placed a polymer stent due to the trauma to the ureter and it will need time to naturally repair.
 
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Brand Name
RESONANCE STENT SET
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key11151113
MDR Text Key226227847
Report Number3005580113-2021-00005
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 Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRMS-060020-R
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/16/2020
Event Location Hospital
Date Report to Manufacturer01/11/2021
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;
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