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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PALINDROMECHRONIC CATHETER KIT 83 CM GUIDEWIRE
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COVIDIEN PALINDROMECHRONIC CATHETER KIT 83 CM GUIDEWIRE Back to Search Results
Lot Number PALINDROME - 235522X
Device Problems Positioning Failure (1158); Failure to Advance (2524)
Patient Problem No Code Available (3191)
Event Date 04/10/2017
Event Type  Injury  
Event Description
First: cordis aquatrack hydrophilic nitinol guidewire 180 cm the surgeon was informed.Second: palindrome chronic catheter kit 83 cm guidewire.Placement of a right internal jugular line was attempted; however after several attempts with both the palindrome and the cordis guide wire, neither wire would pass.Following surgery as part of the follow-up with failed line placement a cxr was taken to rule out pneumothorax.The radiologist following reading the image contacted the surgeon to inform the surgeon that a piece of retained wire was seen in the right neck area (approx 7 cm).The two guide wires used in the procedure had already been discarded and the operating room suite cleaned.The patient was informed and later sent to another hospital where the wire was removed without further incident reported.On follow-up with the hospital we were not able to confirm and identify the wire removed.They too had discarded the wire removed.
 
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Brand Name
PALINDROMECHRONIC CATHETER KIT 83 CM GUIDEWIRE
Type of Device
GUIDEWIRE
Manufacturer (Section D)
COVIDIEN
MDR Report Key6861538
MDR Text Key86143647
Report NumberMW5072122
Device Sequence Number2
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/11/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberPALINDROME - 235522X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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