BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH INF .038 F4 110 6 PIG-145

    MDR report key: 1870079 · Received October 15, 2010

    Report

    Report Number
    9616099-2010-00793
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 17, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K862244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM AN ACCOUNT INDICATED THAT A 4FR PIGTAIL CATHETER BROKE IN TWO PIECES INSIDE THE PATIENT. THE PHYSICIAN TOOK THE PIGTAIL CATHETER ACROSS THE AORTIC VALVE AND INTO THE LEFT VENTRICLE WITH NO PROBLEMS. UPON CONTRAST INJECTION, IT WAS NOTED THAT THE PIGTAIL WAS NO LONGER IN THE LEFT VENTRICLE. THE PATIENT COMPLAINED OF PAIN IN HIS BACK AND UPON CLOSER INSPECTION UNDER FLUOROSCOPY, THE PIGTAIL CATHETER WAS NOTED TO HAVE BROKEN IN TWO PIECES. THE PROXIMAL END OF THE CATHETER HAD BROKEN OFF AND WAS IN THE AORTA. THE DISTAL END WAS REMOVED FROM THE PATIENT VIA THE FEMORAL SHEATH. THE PHYSICIAN THEN HAD TO REMOVE THE PROXIMAL PART OF THE PIGTAIL CATHETER WITH A SNARE, WHICH TOOK 1 HOUR AND 45 MINUTES. THE PATIENT WAS MONITORED POST PROCEDURE FOR ANY COMPLICATIONS BUT NONE WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ACCORDING TO THE ACCOUNT THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE, NO EXCESSIVE TORQUING WAS REQUIRED, NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE, THE VALVE WAS NOT STENOSED AND THE CATHETER RESTERILIZED. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS RETURNED FOR EVALUATION. ONE NON STERILE 4F DIAGNOSTIC CATHETER WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE CATHETER WAS RECEIVED SEPARATED AT THE BODY AREA, NOT AT THE FUSING AREA, IN TWO SECTIONS AT 47 CM FROM THE DISTAL END. ELONGATION AND LUMEN DEFORMATION WERE OBSERVED THROUGH THE WHOLE CIRCUMFERENCE OF THE BODY AT THE DETACHED AREA, BLOOD RESIDUALS WERE OBSERVED. THE INNER AND OUTER DIAMETER OF THE CATHETER BODY WAS MEASURED AND THEY WERE FOUND WITHIN SPECIFICATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED CUSTOMER COMPLAINT OF BODY/SHAFT SEPARATED WAS CONFIRMED THROUGH FAILURE ANALYSIS. ALTHOUGH THE ACCOUNT INDICATED THAT THERE WAS NO DIFFICULTY DELIVERING THE DEVICE TO THE LEFT VENTRICLE, THE CONDITION OF THE DEVICE (ELONGATION AND LUMEN DEFORMATION) INDICATES THAT THE DEVICE WAS OVER TORQUED PRIOR TO THE SEPARATION EITHER FROM THE CATHETER BECOMING KINKED OR A TORTUOUS AORTA. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN TOOK THE PIGTAIL CATHETER ACROSS THE AORTIC VALVE AND INTO THE LEFT VENTRICLE WITH NO PROBLEMS. UPON CONTRAST INJECTION IT WAS NOTED THAT THE PIGTAIL WAS NO LONGER IN THE LEFT VENTRICLE. THE PATIENT COMPLAINED OF PAIN IN HIS BACK AND UPON CLOSER INSPECTION UNDER FLUOROSCOPY, THE PIGTAIL CATHETER WAS NOTED TO HAVE BROKEN IN TWO PIECES. THE PROXIMAL END OF THE CATHETER HAD BROKEN OFF AND WAS IN THE AORTA. THE DISTAL END WAS REMOVED FROM THE PATIENT VIA THE FEMORAL SHEATH. THE PHYSICIAN THEN HAD TO REMOVE THE PROXIMAL PART OF THE PIGTAIL CATHETER WITH A SNARE, WHICH TOOK 1 HOUR AND 45 MINUTES. THE PATIENT WAS MONITORED POST PROCEDURE FOR ANY COMPLICATIONS BUT NONE WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. NO EXCESSIVE TORQUING WAS REQUIRED. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE VALVE WAS NOT STENOSED. THE CATHETER WAS NOT RESTERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH INF .038 F4 110 6 PIG-145 DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO 15045819

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention