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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER
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COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number MPIS-501-NT-SST
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/07/2015
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
Prior to patient contact for a coronary angiogram, it was observed that the dilator was faulty upon opening the micropuncture set, the tip was noted to be jagged and torn.It was further noted that the outer catheter was damaged and no adverse effects were reported as a result of this product problem.
 
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Brand Name
MICROPUNCTURE TRANSITIONLESS ACCESS SET
Common Device Name
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6739667
Report Number1820334-2017-02009
Device Sequence Number19143337
Product Code DYB
UDI-Device Identifier00827002438705
UDI-Public(01)00827002438705(17)180617(10)5967260
Combination Product (Y/N)N
Initial Reporter CountryZA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/24/2017
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 NumberMPIS-501-NT-SST
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2017
Initial Report FDA Received Date07/25/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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