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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 02/22/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
When attempting to exchange sheaths, it was noted that the end user was unable to insert into the shuttle sheath because the distal tip had cracked.The procedure was completed with another product.There were no adverse consequences reported as a result of this issue.
 
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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 Key6577143
Report Number1820334-2017-01167
Device Sequence Number16463496
Product Code DYB
UDI-Device Identifier00827002128354
UDI-Public(01)00827002128354(17)180825(10)6150987
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) 05/18/2017
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-7.0-38-90-RB-SHTL-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 Date05/18/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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