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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 KSAW-7.0-18/38-55-RB-ANL1-HC
Health Effect - Clinical Code Occlusion (1984)
Date of Event 12/13/2016
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
While preparing to treat chronic total occlusion in the superior femoral artery, the physician discovered that the dilator tip was frayed.This occurred prior to patient contact, and the procedure was completed with a different device.There have been no injuries or additional medical intervention reported.
 
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Brand Name
FLEXOR ANSEL GUIDING SHEATH
Common Device Name
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6571789
Report Number1820334-2017-01204
Device Sequence Number16427619
Product Code DYB
UDI-Device Identifier00827002299993
UDI-Public(01)00827002299993(17)190420(10)6903349
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 Physician
Type of Report Initial
Report Date (Section B) 05/17/2017
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 NumberKSAW-7.0-18/38-55-RB-ANL1-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 Date05/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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