BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI BRITE TIP UNKNOWN

    MDR report key: 2864080 · Received December 10, 2012

    Report

    Report Number
    9616099-2012-00697
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    February 1, 2002
    Report Date
    November 7, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE TARGET LESION WAS REACHED AND DILATED SUCCESSFULLY WITH MAXIMAL 8 ATM, A 3.0 MM X 32 MM NIR STENT (BOSTON SCIENTIFIC, (B)(4)) WAS IMPLANTED WITH MAXIMAL 12 ATM AND NO RESIDUAL STENOSIS WAS OBSERVED AFTERWARD. HOWEVER, AFTER CLEANING THE TABLE IN THE CATHETERIZATION LABORATORY, THE SOFT RING ON THE TIP OF THE AMPLATZ LEFT GUIDING CATHETER WAS FOUND MISSING. ON REVIEWING THE PROCEDURE VIDEOTAPE, THE MISSING RADIOPAQUE RING OF THE AMPLATZ CATHETER WAS FOUND IN THE PROXIMAL SEGMENT OF RCA, CLOSE TO THE CALCIFIED OPACITY SPOTS. THE RADIOPAQUE RING WAS THOUGHT TO HAVE LOOSENED AND SEPARATED DURING THE MANIPULATION OF THE BALLOON MOUNTED WITH STENT. THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LABORATORY, WHERE A MAGNUM GUIDEWIRE ((B)(6)) WAS MANIPULATED TO GO THROUGH THE RADIOPAQUE RING TO THE DISTAL SEGMENT, AND THEN TRIED TO PASS THE RING WITH A 2.5 MM BALLOON, WHICH WAS SMALLER THAN THE ACTUAL INNER LUMINAL DIAMETER. UNFORTUNATELY, THE RING SLID DOWNWARD WITH ALMOST EVERY PUSH OF THE BALLOON CATHETER. AFTER THE BALLOON WAS COMPLETELY PASSED THROUGH THE RING, THE RING ALSO SLID DOWN TO THE MIDDLE SEGMENT OF THE RCA AND THE BALLOON WAS INFLATED UP TO 4 ATM. THE RING WAS DRAGGED BACKWARD WITH THE BALLOON INFLATED ON ITS DISTAL END. THE PROCEDURE WAS DONE UNDER FLUOROSCOPIC GUIDANCE UNTIL THE RING WAS OUT OF THE RCA AND INTO THE GUIDING CATHETER. THEN THE GUIDING CATHETER, ALONG WITH THE RING, INFLATED BALLOON, AND WIRE, WAS PULLED OUT FROM THE FEMORAL SHEATH. THE FINAL ANGIOGRAM OF THE RCA REVEALED NO RESIDUAL MATERIAL LEFT INSIDE, NOR WAS THERE ANY THROMBOSIS OR ARTERY OCCLUSION OR ANGINA AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED AFTER THE THIRD HOSPITAL DAY AND FOLLOWED UP FOR MORE THAN 6 MONTHS WITHOUT ANY ADVERSE EVENT. CONCLUSION: INFORMATION CONTAINED IN A LITERATURE REVIEW INDICATED THAT THE RADIOPAQUE RING OF A GUIDING CATHETER DEHISCED DURING THE IMPLANT OF A STENT IN THE RIGHT CORONARY ARTERY. THE RING WAS SUCCESSFULLY RETRIEVED WITH A GUIDEWIRE AND A BALLOON CATHETER WITHOUT SURGERY. A (B)(6) FEMALE WAS REFERRED TO THE HOSPITAL AFTER SUCCESSFUL DEFIBRILLATION FOR VENTRICULAR TACHYCARDIA IN A LOCAL CLINIC. AT PRESENTATION, SHE WAS CONSCIOUS AND COHERENT, WITH A BLOOD PRESSURE OF 140/91 MM HG, A PULSE RATE OF 87/MIN REGULAR RHYTHM; 12-LEAD ECG SHOWED NO ABNORMAL Q-WAVE, AND ECHOCARDIOGRAM SHOWED AKINESIA OF THE INFERIOR AND POSTERIOR SEGMENTS OF LEFT VENTRICLE. CORONARY ARTERIOGRAPHY SHOWED TRIPLE-VESSEL DISEASE WITH THE CULPRIT LESION BEING A TIGHT SEGMENTAL LESION WITH 90% STENOSIS ON THE MIDDLE SEGMENT OF RCA, AND POOR FILLING IN THE DISTAL SEGMENT. THE PROXIMAL RCA HAD A SHARP SHEPHERD'S CROOK WITH MULTIPLE VISIBLE CALCIFIED SPOTS. A 7 FR AMPLATZ LEFT GUIDING CATHETER ((B)(4)) WAS SELECTED TO APPROACH THE LESION. THIS GUIDING CATHETER HAS A SOFT RADIOPAQUE SOFT RUB RING, WHICH COULD BE VISUALIZED SITTING AGAINST THE PROXIMAL LIMB OF THE SHEPHERD'S CROOK UNDER THE FLUOROSCOPE. THEN A 3.0 MM X 30 MM EUROPASS DILATATION BALLOON OVER THE GUIDEWIRE WAS ADVANCED THROUGH THE GUIDING CATHETER TO THE TARGET LESION, WHICH WAS LOCATED BELOW A SHARP CALCIFIED SHEPHERD'S CURVE ON THE MIDDLE SEGMENT OF THE RCA. THE LESION WAS DIFFICULT TO PASS, DEMANDING A LOT OF MANIPULATION OF THE GUIDEWIRE, AND KEPT THE TIP OF THE GUIDING CATHETER FIRMLY RESTING ON THE ORIFICE OF RCA. WHEN THE TARGET LESION WAS REACHED AND DILATED SUCCESSFULLY WITH MAXIMAL 8 ATM, A 3.0 MM X 32 MM NIR STENT (BOSTON SCIENTIFIC, BOSTON, MA) WAS IMPLANTED WITH MAXIMAL 12 ATM AND NO RESIDUAL STENOSIS WAS OBSERVED AFTERWARD. HOWEVER, AFTER CLEANING THE TABLE IN THE CATHETERIZATION LABORATORY, THE SOFT RING ON THE TIP OF THE AMPLATZ LEFT GUIDING CATHETER WAS FOUND MISSING. ON REVIEWING THE PROCEDURE VIDEOTAPE, THE MISSING RADIOPAQUE RING OF THE AMPLATZ CATHETER WAS FOUND IN THE PROXIMAL SEGMENT OF RCA, CLOSE TO THE CALCIFIED OPACITY SPOTS. THE RADIOPAQUE RING WAS THOUGHT TO HAVE LOOSENED AND SEPARATED DURING THE MANIPULATION OF THE BALLOON MOUNTED WITH STENT. THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LABORATORY, WHERE A MAGNUM GUIDEWIRE ((B)(6)) WAS MANIPULATED TO GO THROUGH THE RADIOPAQUE RING TO THE DISTAL SEGMENT, AND THEN TRIED TO PASS THE RING WITH A 2.5 MM BALLOON, WHICH WAS SMALLER THAN THE ACTUAL INNER LUMINAL DIAMETER. UNFORTUNATELY, THE RING SLID DOWNWARD WITH ALMOST EVERY PUSH OF THE BALLOON CATHETER. AFTER THE BALLOON WAS COMPLETELY PASSED THROUGH THE RING, THE RING ALSO SLID DOWN TO THE MIDDLE SEGMENT OF THE RCA AND THE BALLOON WAS INFLATED UP TO 4 ATM. THE RING WAS DRAGGED BACKWARD WITH THE BALLOON INFLATED ON ITS DISTAL END. THE PROCEDURE WAS DONE UNDER FLUOROSCOPIC GUIDANCE UNTIL THE RING WAS OUT OF THE RCA AND INTO THE GUIDING CATHETER. THEN THE GUIDING CATHETER, ALONG WITH THE RING, INFLATED BALLOON, AND WIRE, WAS PULLED OUT FROM THE FEMORAL SHEATH. THE FINAL ANGIOGRAM OF THE RCA REVEALED NO RESIDUAL MATERIAL LEFT INSIDE, NOR WAS THERE ANY THROMBOSIS OR ARTERY OCCLUSION OR ANGINA AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED AFTER THE THIRD HOSPITAL DAY AND FOLLOWED UP FOR MORE THAN 6 MONTHS WITHOUT ANY ADVERSE EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. WITHOUT THE RETURN OF THE DEVICE OR FILMS AVAILABLE FOR REVIEW THE INFORMATION CONTAINED IN THE LITERATURE REVIEW COULD NOT BE CONFIRMED. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL CHARACTERISTICS AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. PLEASE NOTE THAT THE EVENT DATE IS UNKNOWN. THE EVENT DATE HAS BEEN INSERTED AS THE PUBLICATION DATE OF THE ARTICLE.

    Description of Event or Problem · 1

    FANG ET AL INTRACORONARY RETRIEVAL OF THE DEHISCED RADIOPAQUE RING OF A GUIDING CATHETER: AN UNUSUAL COMPLICATION OF CORONARY ANGIOPLASTY. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. 55(2):262-4, 2002 FEB.; REPORT A DEHISCED RADIOPAQUE RING FROM A CORDIS GUIDING CATHETER INTO THE RIGHT CORONARY ARTERY (RCA) DURING STENTING. THE RING WAS SUCCESSFULLY RETRIEVED WITH A GUIDEWIRE AND A BALLOON CATHETER WITHOUT SURGERY. A (B)(6) FEMALE WAS REFERRED TO THE HOSPITAL AFTER SUCCESSFUL DEFIBRILLATION FOR VENTRICULAR TACHYCARDIA IN A LOCAL CLINIC. AT PRESENTATION, SHE WAS CONSCIOUS AND COHERENT, WITH A BLOOD PRESSURE OF 140/91 MM HG, A PULSE RATE OF 87/MIN REGULAR RHYTHM; 12-LEAD ECG SHOWED NO ABNORMAL Q-WAVE, AND ECHOCARDIOGRAM SHOWED AKINESIA OF THE INFERIOR AND POSTERIOR SEGMENTS OF LEFT VENTRICLE. CORONARY ARTERIOGRAPHY SHOWED TRIPLE-VESSEL DISEASE WITH THE CULPRIT LESION BEING A TIGHT SEGMENTAL LESION WITH 90% STENOSIS ON THE MIDDLE SEGMENT OF RCA, AND POOR FILLING IN THE DISTAL SEGMENT. THE PROXIMAL RCA HAD A SHARP SHEPHERD'S CROOK WITH MULTIPLE VISIBLE CALCIFIED SPOTS. A 7 FR AMPLATZ LEFT GUIDING CATHETER (CORDIS, (B)(4)) WAS SELECTED TO APPROACH THE LESION. THIS GUIDING CATHETER HAS A SOFT RADIOPAQUE SOFT RUB RING, WHICH COULD BE VISUALIZED SITTING AGAINST THE PROXIMAL LIMB OF THE SHEPHERD'S CROOK UNDER THE FLUOROSCOPE. THEN A 3.0 MM X 30 MM EUROPASS DILATATION BALLOON OVER THE GUIDEWIRE WAS ADVANCED THROUGH THE GUIDING CATHETER TO THE TARGET LESION, WHICH WAS LOCATED BELOW A SHARP CALCIFIED SHEPHERD'S CURVE ON THE MIDDLE SEGMENT OF THE RCA. THE LESION WAS DIFFICULT TO PASS, DEMANDING A LOT OF MANIPULATION OF THE GUIDEWIRE, AND KEPT THE TIP OF THE GUIDING CATHETER FIRMLY RESTING ON THE ORIFICE OF RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP UNKNOWN ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R EUROPASS BALLOON, 3 X 32 NIR STENT