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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 10/12/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol_cap008, compliant/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
The customer found that the sheath was split at the proximal end, prior to insertion into the patient. Another device was used to complete the procedure. No parts of the device remained inside the patient. No adverse events were reported.
 
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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 Key6569304
MDR Text Key75412800
Report Number1820334-2017-01181
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002299832
UDI-Public(01)00827002299832(17)180403(10)5777322
Combination Product (y/n)N
Reporter Country CodeTW
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 05/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
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? Yes
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 Manufactured04/03/2015
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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