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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. ONE-PART PERCUTANEOUS ENTRY NEEDLE TROCAR

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COOK, INC. ONE-PART PERCUTANEOUS ENTRY NEEDLE TROCAR Back to Search Results
Device Problems Break (1069); Retraction Problem (1536); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/18/2022
Event Type  Injury  
Event Description
While getting access for a cardiac catheterization, using a cook 21g access needle (reference number sdn-21-7. 0, order number g01618), after obtaining femoral arterial blood return, i inserted a 0. 021" nitinol wire that comes in the terumo pinnacle precision access system (order no/ref: 70-5160, lot no 0000057614). I appreciated resistance shortly after exiting the needle. I tried to retract the wire to reorient it, and it wouldn't come back. I removed the needle and the wire, but when the needle came out the wire was still in the patient, obviously unraveling. After contralateral arterial access demonstrated that the wire tip was not in the arterial system (such that i couldn't snare it and remove it), we elected to try to remove the wire through our access point. It unfortunately unraveled and broke, leaving about 1 inch length of the wire tip in the soft tissue of the right groin.
 
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Brand NameONE-PART PERCUTANEOUS ENTRY NEEDLE
Type of DeviceTROCAR
Manufacturer (Section D)
COOK, INC.
MDR Report Key13600623
MDR Text Key286348988
Report NumberMW5107704
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/22/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 02/24/2022 Patient Sequence Number: 1
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