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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER

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COOK INC FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-6.0-18/38-45-RB-ANL2-HC
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2015
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
The reported information indicated that the sheath's tip was split open before the procedure. According to the initial reporter, there were no adverse effects on the patient as a result of the event. A section of the device did not remain inside the patient¿s body and no additional procedures were required due to the occurrence.
 
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Brand NameFLEXOR ANSEL GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6575599
MDR Text Key75629647
Report Number1820334-2017-01200
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002299832
UDI-Public(01)00827002299832(17)180710(10)6023204
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKCFW-6.0-18/38-45-RB-ANL2-HC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2015
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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