BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FRONTRUNNER

    MDR report key: 3030574 · Received April 2, 2013

    Report

    Report Number
    9616099-2013-00201
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 1, 2005
    Report Date
    March 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K033535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CONCLUSION HAS BEEN UPDATED AS THE ORIGINAL CONCLUSION REFERRED TO THE OUTBACK CATHETER AS THE COMPLAINT PRODUCT WHEN ACTUALLY THE ARTICLE REFERS TO THE FRONTRUNNER CATHETER AS THE COMPLAINT PRODUCT. DURING A LITERATURE SEARCH FOR CTO DEVICES, THE FOLLOWING ARTICLE WAS FOUND: COLOMBO ET AL PRELIMINARY EXPERIENCE WITH THE FRONTRUNNER CATHETER; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 64: 146-152 (2005); BETWEEN (B)(6) 2000 AND (B)(6) 2003, (B)(4) PATIENTS WITH 50 CTOS WERE INCLUDED IN A STUDY OF (B)(4). THIS DEVICE IS DEDICATED TO RECANALIZATION OF CHRONIC TOTAL OCCLUSIONS (CTOS), RELIES ON BLUNT MICRO DISSECTIONS INSIDE THE PLAQUE, ALLOWING PASSAGE OF GUIDEWIRE THROUGH THE LESION AND ADJUNCTIVE ANGIOPLASTY. THE DISTAL TIP OF THE FRONTRUNNER CATHETER JAWS ARE CLOSED DURING ADVANCEMENT THROUGHOUT THE OCCLUSION AND RETRIEVAL OF THE DEVICE. THE JAWS ARE OPEN DURING BLUNT MICRO DISSECTIONS IN OR AROUND AN OCCLUSIVE PLAQUE. IN (B)(4) OCCLUSIONS, THE FCC DEVICE WAS THE FIRST ATTEMPTED DEVICE AND ANGIOGRAPHIC SUCCESS WAS OBTAINED IN (B)(4) OF THEM. CORONARY PERFORATION OCCURRED IN NINE PATIENTS, LEADING TO TAMPONADE IN (B)(4) PATIENTS WHO WERE TREATED WITH PERICARDIOCENTESIS. TWO CORONARY PERFORATIONS APPEARED DURING THE MANIPULATION WITH GUIDEWIRE AND SEVEN DURING THE USE OF FCC. IN ALL NINE PATIENTS, HEPARIN REVERSION WITH PROTAMINE WAS DONE AND ACCOMPANIED BY PROLONG BALLOON INFLATION IN THREE PATIENTS. ONE OF THESE PATIENTS HAD NON-Q-WAVE MYOCARDIAL INFARCTION AND THE REMAINING EIGHT HAD UNEVENTFUL CLINICAL COURSE IN HOSPITAL AND AT 30-DAY FOLLOW- UP. THE MAIN FINDINGS OF THIS STUDY ARE, ONE, IN CORONARY CHRONIC TOTAL OCCLUSIONS IN WHICH AN ATTEMPT WITH A MECHANICAL WIRE FAILED OR WAS CONSIDERED UNSUITABLE, THE USE OF THE FCC DEVICE INCREASES THE SUCCESS RATE BY (B)(4); TWO, THE RISK OF PERFORATION IS NOT LOW BUT IT SIGNIFICANTLY DECREASES WITH EXPERIENCE; AND THREE, EVEN IF FCC DOES NOT CROSS DIRECTLY THE CTO, IT MAY HELP GAIN THE DISTAL TRUE LUMEN BY MECHANICAL WIRES. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE FRONTRUNNER WAS DESIGNED AND DEVELOPED BY LUMEND, INC. WHICH WAS USED FOR TREATMENT OF CTO IN THE CORONARIES. IN 2005 CORDIS CORPORATION ACQUIRED LUMEND AND THE DEVICE WAS CE MARKED IN (B)(4) 2006. ALTHOUGH THIS ARTICLE WAS PUBLISHED IN 2005, THE PATIENTS INCLUDED IN THE STUDY WERE INTERVENED DURING 2000-2003. AT THE TIME OF CORDIS OWNERSHIP OF THE FRONTRUNNER, THE DEVICE IS NOT INDICATED FOR USE IN THE CORONARY ARTERIES. BASED ON THE INFORMATION PROVIDED, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00201 AND 9616099-2013-00202.

    Additional Manufacturer Narrative · 1

    CONCLUSION: DURING A LITERATURE SEARCH FOR CTO DEVICES, THE FOLLOWING ARTICLE WAS FOUND: COLOMBO ET AL PRELIMINARY EXPERIENCE WITH THE FRONTRUNNER CATHETER; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 64: 146-152 (2005); BETWEEN OCTOBER 2000 AND JUNE 2003, 50 PATIENTS WITH 50 CTOS WERE INCLUDED IN A STUDY OF THE NOVEL DEVICE FRONTRUNNER CORONARY CATHETER (FCC). THIS DEVICE IS DEDICATED TO RECANALIZATION OF CHRONIC TOTAL OCCLUSIONS (CTOS), RELIES ON BLUNT MICRO DISSECTIONS INSIDE THE PLAQUE, ALLOWING PASSAGE OF GUIDEWIRE THROUGH THE LESION AND ADJUNCTIVE ANGIOPLASTY. THE DISTAL TIP OF THE FRONTRUNNER CATHETER JAWS ARE CLOSED DURING ADVANCEMENT THROUGHOUT THE OCCLUSION AND RETRIEVAL OF THE DEVICE. THE JAWS ARE OPEN DURING BLUNT MICRO DISSECTIONS IN OR AROUND AN OCCLUSIVE PLAQUE. IN 18 OCCLUSIONS, THE FCC DEVICE WAS THE FIRST ATTEMPTED DEVICE AND ANGIOGRAPHIC SUCCESS WAS OBTAINED IN 8 OF THEM. CORONARY PERFORATION OCCURRED IN NINE PATIENTS, LEADING TO TAMPONADE IN TWO (4%) PATIENTS WHO WERE TREATED WITH PERICARDIOCENTESIS. TWO CORONARY PERFORATIONS APPEARED DURING THE MANIPULATION WITH GUIDEWIRE AND SEVEN DURING THE USE OF FCC. IN ALL NINE PATIENTS, HEPARIN REVERSION WITH PROTAMINE WAS DONE AND ACCOMPANIED BY PROLONG BALLOON INFLATION IN THREE PATIENTS. ONE OF THESE PATIENTS HAD NON-Q-WAVE MYOCARDIAL INFARCTION AND THE REMAINING EIGHT HAD UNEVENTFUL CLINICAL COURSE IN HOSPITAL AND AT 30-DAY FOLLOW- UP. THE MAIN FINDINGS OF THIS STUDY ARE, ONE, IN CORONARY CHRONIC TOTAL OCCLUSIONS IN WHICH AN ATTEMPT WITH A MECHANICAL WIRE FAILED OR WAS CONSIDERED UNSUITABLE, THE USE OF THE FCC DEVICE INCREASES THE SUCCESS RATE BY 50%; TWO, THE RISK OF PERFORATION IS NOT LOW BUT IT SIGNIFICANTLY DECREASES WITH EXPERIENCE; AND THREE, EVEN IF FCC DOES NOT CROSS DIRECTLY THE CTO, IT MAY HELP GAIN THE DISTAL TRUE LUMEN BY MECHANICAL WIRES. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE OUTBACK LTD RE-ENTRY CATHETER WAS DESIGNED AND DEVELOPED BY LUMEND, INC., AND SUBSEQUENTLY TRANSFERRED TO PERCLOSE, INC. THE OUTBACK CATHETER WAS ORIGINALLY CLEARED IN 2001 BY THE U.S. FDA FOR USE IN THE PERIPHERAL VASCULATURE. IN 2002, ABBOTT LABORATORIES PURCHASED PERCLOSE. IN 2004, THE OUTBACK CATHETER WAS TRANSFERRED FROM ABBOTT LABS BACK TO LUMEND; AND IN 2005 CORDIS CORPORATION ACQUIRED LUMEND. THE CURRENT VERSION OF THE OUTBACK LTD-RE- ENTRY CATHETER WAS CLEARED FOR U.S. SALE IN 2005 (K043534), AND THE DEVICE WAS CE MARKED IN APRIL 2006. ALTHOUGH THIS ARTICLE WAS PUBLISHED IN 2005, THE PATIENTS INCLUDED IN THE STUDY WERE INTERVENED DURING 2000-2003. AT THE TIME OF CORDIS OWNERSHIP, THE FRONTRUNNER WAS NOT INDICATED FOR USE IN THE CORONARY ARTERIES. BASED ON THE INFORMATION PROVIDED, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    COLOMBO ET AL PRELIMINARY EXPERIENCE WITH THE FRONTRUNNER CATHETER; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 64: 146-152; BETWEEN OCTOBER 2000 AND JUNE 2003, 50 PATIENTS WITH 50 CTOS WERE INCLUDED IN A STUDY OF THE NOVEL DEVICE FRONTRUNNER CORONARY CATHETER (FCC). THIS DEVICE IS DEDICATED TO RECANALIZATION OF CHRONIC TOTAL OCCLUSIONS (CTOS), RELIES ON BLUNT MICRO DISSECTIONS INSIDE THE PLAQUE, ALLOWING PASSAGE OF GUIDEWIRE THROUGH THE LESION AND ADJUNCTIVE ANGIOPLASTY. THE DISTAL TIP OF THE FRONTRUNNER CATHETER JAWS ARE CLOSED DURING ADVANCEMENT THROUGHOUT THE OCCLUSION AND RETRIEVAL OF THE DEVICE. THE JAWS ARE OPEN DURING BLUNT MICRO DISSECTIONS IN OR AROUND AN OCCLUSIVE PLAQUE. IN 18 OCCLUSIONS, THE FCC DEVICE WAS THE FIRST ATTEMPTED DEVICE AND ANGIOGRAPHIC SUCCESS WAS OBTAINED IN 8 OF THEM. CORONARY PERFORATION OCCURRED IN NINE PATIENTS, LEADING TO TAMPONADE IN TWO (4%) PATIENTS WHO WERE TREATED WITH PERICARDIOCENTESIS. TWO CORONARY PERFORATIONS APPEARED DURING THE MANIPULATION WITH GUIDEWIRE AND SEVEN DURING THE USE OF FCC. IN ALL NINE PATIENTS, HEPARIN REVERSION WITH PROTAMINE WAS DONE AND ACCOMPANIED BY PROLONG BALLOON INFLATION IN THREE PATIENTS. ONE OF THESE PATIENTS HAD NON-Q-WAVE MYOCARDIAL INFARCTION AND THE REMAINING EIGHT HAD UNEVENTFUL CLINICAL COURSE IN HOSPITAL AND AT 30-DAY FOLLOW- UP. THE MAIN FINDINGS OF THIS STUDY ARE, ONE, IN CORONARY CHRONIC TOTAL OCCLUSIONS IN WHICH AN ATTEMPT WITH A MECHANICAL WIRE FAILED OR WAS CONSIDERED UNSUITABLE, THE USE OF THE FCC DEVICE INCREASES THE SUCCESS RATE BY 50%; TWO, THE RISK OF PERFORATION IS NOT LOW BUT IT SIGNIFICANTLY DECREASES WITH EXPERIENCE; AND THREE, EVEN IF FCC DOES NOT CROSS DIRECTLY THE CTO, IT MAY HELP GAIN THE DISTAL TRUE LUMEN BY MECHANICAL WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134500 UNKNOWN FRONTRUNNER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R