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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER
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COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-12.0-35-45-RB-HFANL1-HC
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/24/2016
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that the product would not turn completely.Photos of the returned device revealed that the tip of the sheath was damaged and slightly torn.The device was used during a procedure, but there was no report of patient injury or additional medical intervention.
 
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Brand Name
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
Common Device Name
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6568155
Report Number1820334-2017-01120
Device Sequence Number612998
Product Code DYB
UDI-Device Identifier00827002477018
UDI-Public(01)00827002477018(17)180612(10)5953691
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberKCFW-12.0-35-45-RB-HFANL1-HC
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/10/2017
Initial Report FDA Received Date05/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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