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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR BALKIN GUIDING SHEATH; DYB INTRODUCER, CATHETER
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COOK INC FLEXOR BALKIN GUIDING SHEATH; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-6.0-38-40-RB-BLKN-HC
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/28/2015
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
At the moment the doctor tried to put the sheath through the skin into the vessel, it gives a crack at the tip of the sheath.A gouge in the sheath tip caused the tip to be out of round.There were no adverse effects to the patient associated with the occurrence.
 
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Brand Name
FLEXOR BALKIN GUIDING SHEATH
Common Device Name
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6567630
Report Number1820334-2017-01136
Device Sequence Number736527
Product Code DYB
UDI-Device Identifier00827002322240
UDI-Public(01)00827002322240(17)170723(10)5152890
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
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-6.0-38-40-RB-BLKN-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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