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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
Lot Number 13585145
Device Problems Fracture (1260); Failure to Advance (2524)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/27/2021
Event Type  malfunction  
Event Description
During placement of port-a-cath in interventional radiology, the left internal jugular vein was visualized under fluoroscopy with image documentation of needle entry into the lij (left internal jugular).An attempt to advance the guidewire centrally was unsuccessful and in removing the needle and guidewire, the guidewire was fractured, and a segment was lodged in the subcutaneous tissue.Attempts at removal were unsuccessful and surgery was called in for assistance.Surgeon was able to extend the incision by 1cm to allow for dissection and was able to grasp the tissue in which the guidewire tip was embedded, this allowed her to locate the guidewire itself and remove it.Radiologist was then able to complete port-a-cath placement without any further incident.
 
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Brand Name
MICROPUNCTURE
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key11284984
MDR Text Key230467020
Report Number11284984
Device Sequence Number1
Product Code DYB
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 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number13585145
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2021
Event Location Hospital
Date Report to Manufacturer02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14965 DA
Patient Weight88
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