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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER

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COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number MPIS-401-10.0-SC-NT-SST
Device Problems Material Separation (1562); Split (2537)
Patient Problem No Code Available (3191)
Event Date 01/15/2018
Event Type  Injury  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged. Additional/ corrected information: narrative
=
per information received on 26jan2018, the patient's anatomy was reported to be heavily scarred but not tortuous or calcified. This report includes information known at this time.  a follow-up report will be submitted should additional relevant information become available.
 
Manufacturer Narrative
(b)(4). This report includes information known at this time.  a follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that during a cerebral angiogram, the micropuncture transitionless stiffened cannula access set coaxial catheter broke in half inside of the patient's anatomy. The portion of the catheter with the tip remained on the wire guide being utilized. Access was obtained from the other side in order to cut down and successfully retrieve the broken catheter portions. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameMICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7222934
MDR Text Key283242810
Report Number1820334-2018-00173
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002480032
UDI-Public(01)00827002480032(17)201121(10)8393541
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMPIS-401-10.0-SC-NT-SST
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/26/2018 Patient Sequence Number: 1
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