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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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COOK INCORPORATED MICROPUNCTURE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number G48007
Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2018
Event Type  malfunction  
Event Description
During procedure catheter broke in patient, doctor consulted for retrieval, successfully removed. Cerebral angiogram with intervention. Catheter broke in artery. Consult to radiology interventional to retrieve. Subarachnoid hemorrhage -- cerebral angiogram with neurosurgeon. Dilator broke on attempt to remove from right common femoral artery after failed attempt to advance dilator. Doctor consulted intraprocedure and retrieved the broken dilator. Procedure continued after accessing the left common femoral artery. Using a micro puncture set to gain access in the groin area for a procedure, the tip of the micropuncture broke off and was logged close to the surface of the skin. A new micro puncture set was opened and used, access gained and the procedure completed without any further issues. Micropuncture introducer set silhouette transition less push-plus design stiffened cannula.
 
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Brand NameMICROPUNCTURE
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key7494221
MDR Text Key107592422
Report Number7494221
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG48007
Device Catalogue NumberMPIS-501-10.0-SC-NT-SST
Device Lot Number8507990
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/02/2018
Event Location Hospital
Date Report to Manufacturer05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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