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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NSNARE STENT RETRIEVER FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NSNARE STENT RETRIEVER FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NSR-024115
Device Problems Break (1069); Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that a physician was performing ureteroscopy to remove a ureteral stent that had migrated up the ureter. When the stent was being engaged by the stone extractor a basket formation wire broke. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameNSNARE STENT RETRIEVER
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7135109
MDR Text Key95919605
Report Number1820334-2017-04536
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNSR-024115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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