BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERTORQUE FLUSH CATHETERS

    MDR report key: 3013950 · Received March 20, 2013

    Report

    Report Number
    9616099-2013-00163
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 27, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K915836
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA ATTACHED VOLUNTARY MEDWATCH REPORT FILED WITH THE FDA. "ANGIOGRAM IN PROCESS CATHETER FRACTURED WHILE TRYING TO ACCEWS THE LEFT COMMON CAROTID ARTERY. PT HAD TO BE TAKEN TO THE OPERATING ROOM FOR EMERGENCY RIGHT FEMORAL CUTDOWN AND EXPLORATION OF RIGHT RETROPERITONEUM FOR REMOVAL OF CATHETER AND REPAIR OF PERFORATED MID RIGHT EXTERNAL ILIAC ARTERY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE NEW EVENT IS ALSO ASSOCIATED WITH ASSOCIATED REPORT NUMBER 9616099-2013-00236 AND THIS REPORT NUMBER, 9616099-2013-00163. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS ALSO RECEIVED THAT THE DEVICE SEPARATED ON THE HYPOTUBE AND ON THE SHAFT. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE INSERTED INSERTED THROUGH THE SHEATH. THE DEVICE BELIEVED TO HAVE CAUSED THE PERFORATION IS THE 5 FR SIM 2 SUPER TORQUE ANGIOGRAPHIC CATHETER . AFTER PERFORMING THE RIGHT COMMON CAROTID ARTERIOGRAM, AN ATTEMPT WAS MADE TO SELECTIVELY CATHETERIZE THE LEFT COMMON CAROTID ARTERY. DURING THIS ATTEMPT AND WHILE MANIPULATING THE CATHETER , THE CATHETER BROKE OFF PROXIMALLY IN THE RIGHT EXTERNAL ILIAC ARTERY (ATTEMPTS TO SNARE THE DETACHED CATHETER UNSUCCESSFUL USING GOOSE-NECK AND EN-SNARE DEVICES). DURING OPERATION FOR EMERGENCY RIGHT FEMORAL CUTDOWN AND EXPLORATION OF RIGHT PERITONEUM FOR FRACTURED CATHETER, THERE WAS A PERFORATION OF THE MID RIGHT EXTERNAL ILIAC ARTERY AND THE FRACTURED DIAGNOSTIC SIMMONS 2 CATHETER WAS PROTRUDING INTO THE RETROPERITONEUM THROUGH THE PERFORATED ARTERY. THE PATIENT WAS DISCHARGED HOME WITH HOSPICE FOR COMFORT CARE AND NO MEDICAL TREATMENT FOR INTRAVENTRICULAR HEMORRHAGE (PATIENT CAME INTO HOSPITAL WITH THIS). SURGICAL INTERVENTION NOT INDICATED. INTRAVENTRICULAR HEMORRHAGE (PT CAME INTO HOSPITAL WITH THIS). THE PATIENT IS DECEASED. INFORMATION PROVIDED BY A SALES REPRESENTATIVE AND CONTAINED IN A VOLUNTARY MED WATCH INDICATED THAT A 5FR SUPERTORQUE CATHETER FRACTURED AND SEPARATED IN A PATIENT RESULTING IN A PERFORATED ILIAC ARTERY AND REQUIRING SURGICAL REMOVAL OF THE DEVICE. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN OTHER THAN THE PATIENT PRESENTED TO THE HOSPITAL WITH AN INTRA-VENTRICULAR HEMORRHAGE. THE PROCEDURE BEING PERFORMED WAS A DIAGNOSTIC CEREBRAL ANGIOGRAM AND THE DIAGNOSTIC CATHETER WAS INSIDE OF THE PATIENT FOR A FEW MINUTES TO TAKE PICTURES OF THE CAROTID AND VERTEBRAL ARTERIES. THE VESSEL CHARACTERISTICS OF THE VESSEL USED TO DELIVER THE CATHETER TO THE TARGET SITE WAS A TYPE II ARCH AND MILD CALCIFICATION. A CORDIS BRITE TIP SHEATH WAS USED FOR ACCESS VIA THE RIGHT COMMON FEMORAL ARTERY. ADDITIONAL INFORMATION FROM THE FACILITY INDICATED THAT: AFTER PERFORMING THE RIGHT COMMON CAROTID ARTERIOGRAM, AN ATTEMPT WAS MADE TO SELECTIVELY CATHETERIZE THE LEFT COMMON CAROTID ARTERY. DURING THIS ATTEMPT AND WHILE MANIPULATING THE CATHETER, THE CATHETER BROKE OFF PROXIMALLY IN THE RIGHT EXTERNAL ILIAC ARTERY (ATTEMPTS TO SNARE THE DETACHED CATHETER UNSUCCESSFUL USING GOOSE-NECK AND EN-SNARE DEVICES). THE CATHETER WAS IN THE PATIENT FOR APPROXIMATELY 24 MINUTES BEFORE IT BROKE. THE LESION WAS MODERATELY CALCIFIED, MODERATELY ANGULATED WITH MODERATE VESSEL TORTUOSITY. THE DEVICE SEPARATED ON THE HYPOTUBE AND ON THE SHAFT. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE WAS INSERTED THROUGH THE SHEATH AND NOT A HEMOSTASIS VALVE. THE PATIENT WAS BROUGHT TO SURGERY FOR REMOVAL OF THE DEVICE. DURING THE OPERATION FOR EMERGENCY RIGHT FEMORAL CUTDOWN AND EXPLORATION OF RIGHT PERITONEUM FOR FRACTURED CATHETER, THERE WAS A PERFORATION OF THE MID RIGHT EXTERNAL ILIAC ARTERY AND THE FRACTURED DIAGNOSTIC CATHETER WAS PROTRUDING INTO THE RETROPERITONEUM THROUGH THE PERFORATED ARTERY. ACCORDING TO THE SITE THE DEVICE BELIEVED TO HAVE CAUSED THE PERFORATION IS THE 5 FR SIM 2 SUPER TORQUE ANGIOGRAPHIC CATHETER. THE PATIENT WAS DISCHARGED HOME WITH HOSPICE FOR COMFORT CARE AND HAS SINCE PASSED AWAY. (B)(4): FOUR PICTURES WERE PROVIDED BY THE SPECIALIST VIA E-MAIL IN ORDER TO PERFORM THE ANALYSIS OF COMPLAINT (B)(4). THE FIRST PICTURE SHOWS A PORTION OF A CATHETER INSIDE OF A PLASTIC BAG, THIS PORTION BELONGS TO PROXIMAL END OF THE CATHETER WHICH INCLUDE THE MOLDING HUB WITH A UNKNOWN DEVICE ATTACHED TO IT, THE SECOND PICTURE SHOW ONE END OF A SEPARATION CONDITION, THE THIRD PICTURE SHOW THE DISTAL PORTION OF A CATHETER COILED INSIDE OF A PLASTIC BAG AND THE FOURTH PICTURE SHOW THE OTHER ONE END OF THE SEPARATION, BESIDES OF SEPARATION CONDITION NO OTHER DAMAGE IS OBSERVED. 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 DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER PICTURES OF THE CATHETER WERE PROVIDED. THE PICTURES DEPICT A SEPARATED CATHETER. ALTHOUGH THE EXACT CAUSE FOR THE EVENT COULD NOT CONCLUSIVELY BE DETERMINED WITHOUT THE RETURN OF THE DEVICE, REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT LESION CHARACTERISTICS (MODERATE CALCIFICATION AND TORTUOSITY) AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW OR THE EVENT DESCRIPTION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A CAROTID PROCEDURE A F SUPERTORQUE DIAGNOSTIC CATHETER FRACTURED IN THE PATIENT REQUIRING SURGICAL REMOVAL. THE DEVICE SEPARATED ABOUT 10 INCHES FROM THE HUB AND WAS USED TO SELECT A CAROTID ARTERY AND FRACTURED WHEN THE PHYSICIAN MANIPULATED IT FROM THE RIGHT TO LEFT CAROTID ARTERY. THE PROCEDURE BEING PERFORMED WAS A DIAGNOSTIC CEREBRAL ANGIOGRAM AND THE DIAGNOSTIC CATHETER WAS INSIDE OF THE PATIENT FOR A FEW MINUTES TO TAKE PICTURES OF THE CAROTID AND VERTEBRAL ARTERIES. THE VESSEL CHARACTERISTICS OF THE VESSEL USED TO DELIVER THE CATHETER TO THE TARGET SITE WAS A TYPE II ARCH AND MILD CALCIFICATION. A CORDIS BRITE TIP SHEATH WAS USED IN THE PROCEDURE. ACCESS WAS VIA THE COMMON FEMORAL ARTERY. THE TARGET LESION WAS MODERATELY CALCIFIED, ANGULATED AND WITH MILD VESSEL TORTUOSITY. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. PICTURES WERE ALSO REQUESTED BUT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115945 SUPERTORQUE FLUSH CATHETERS DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 15457990

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR CORDIS BRITE TIP SHEATH