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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE INTRODUCER, CATHETER

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COOK INCORPORATED MICROPUNCTURE INTRODUCER, CATHETER Back to Search Results
Model Number G48004
Device Problems Entrapment of Device (1212); Material Split, Cut or Torn (4008)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/08/2021
Event Type  malfunction  
Event Description
While trying to access femoral artery for cardiac cath, tip of wire from micropuncture kit sheared off into subcutaneous tissue, physician present.
 
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Brand NameMICROPUNCTURE
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key12553719
MDR Text Key274031378
Report Number12553719
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002480049
UDI-Public(01)00827002480049
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG48004
Device Catalogue NumberMPIS-401-10.0-SC-NT-U-SST
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/15/2021
Event Location Other
Date Report to Manufacturer09/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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