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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE TIBIAL GUIDING SHEATH; DYB INTRODUCER, CATHETER
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COOK INC FLEXOR SHUTTLE TIBIAL GUIDING SHEATH; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KSAW-7.0-38-90-RB-SHTL-HC
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/25/2016
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
The complainant alleged that the dilator did not fit into the sheath nicely and that there was an unknown black substance on the end of dilator.No adverse effects have been reported as a result of this product problem.
 
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Brand Name
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
Common Device Name
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6590414
Report Number1820334-2017-01155
Device Sequence Number719609
Product Code DYB
UDI-Device Identifier00827002128354
UDI-Public(01)00827002128354(17)190118(10)6530460
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/25/2017
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 No Information
Device Catalogue NumberKSAW-7.0-38-90-RB-SHTL-HC
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/25/2017
Initial Report FDA Received Date05/25/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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