BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAGNOSTIC CARDIOLOGY CATHETER- 6F

    MDR report key: 3688839 · Received March 19, 2014

    Report

    Report Number
    9616099-2014-00196
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 24, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K862244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ASKING FOR ADDITIONAL INFORMATION REGARDING THIS EVENT, THE SURGEON REFERRED THAT THE EVENTS REPORTED IN THE LITERATURE ARE NOT CORRELATED TO THE DEVICE CORDIS (MULTIPURPOSE CATHETER CORDIS). THE EVENTS DESCRIBED ARE PART OF THE ADVERSE EVENTS CORRELATED AT THE CLINIC PRACTICE. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE LOT COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED 30 DAYS UPON RECEIPT. CONCOMITANT DEVICES:TERUMO 100MM 6F GLIDE SHEATH; 0.035IN DIAGNOSTIC EXCHANGE LENGTH WIRE; LARGE TAVI SHEATH; 135CM PERIPHERAL FOX CROSS OTW BALLOON; ABBOTT VASCULAR; SAPIEN XT, EDWARDS LIFESCIENCES; COREVALVE REVOLVING SYSTEM, MEDTRONIC AND PROSTAR, ABBOTT VASCULAR. THE CATALOG CODE PROVIDED (XXXXXXX), REPRESENTS AN UNKNOWN MULTIPURPOSE DIAGNOSTIC CATHETER. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. THIS COMPLAINT WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: CURRAN ET AL A COMPARISON OF THE FEMORAL AND RADIAL CROSSOVER TECHNIQUES FOR VASCULAR ACCESS MANAGEMENT IN TRANSCATHETER AORTIC VALVE IMPLANTATION: THE MILAN EXPERIENCE, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 83 (2014) 156-161.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY CURRAN ET AL A COMPARISON OF THE FEMORAL AND RADIAL CROSSOVER TECHNIQUES FOR VASCULAR ACCESS MANAGEMENT IN TRANSCATHETER AORTIC VALVE IMPLANTATION: THE MILAN EXPERIENCE, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 83 (2014) 156-161; ONE PATIENT IN THE RADIAL CROSSOVER GROUP REQUIRED COVERED STENT IMPLANTATION FOR ILIAC RUPTURE, NECESSITATING CONVERSION TO CONTRALATERAL FEMORAL ACCESS. ACCORDING TO THE ARTICLE, A STUDY WAS CONDUCTED TO COMPARE PATIENT OUTCOMES BASED ON TWO TECHNIQUES USED TO FACILITATE SAFE THERAPEUTIC VASCULAR ACCESS CLOSURE CALLED THE CROSSOVER TECHNIQUE (CT) UTILIZING THE CONTRALATERAL FEMORAL ARTERY OR RADIAL ARTERY. DURING THE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A CORDIS STANDARD 120-CM MULTIPURPOSE CATHETER WAS ADVANCED INTO THE ILIAC ARTERY OF THE THERAPEUTIC ACCESS SITE OVER A STANDARD 0.035-INCH DIAGNOSTIC EXCHANGE LENGTH WIRE. THE MULTIPURPOSE CATHETER FACILITATES BOTH PLACEMENT OF A 0.018 INCH NON-CORDIS ANGIOPLASTY GUIDEWIRE INTO THE DISTAL FEMORAL ARTERY AND FEMORAL ANGIOGRAPHY PRECEDING INSERTION OF THE LARGE TAVI INTRODUCER SHEATH. AFTER THE VALVE DEPLOYMENT, A NON-CORDIS OTW BALLOON IS ADVANCED TO THE THERAPEUTIC ACCESS SITE IN THE FEMORAL ARTERY, AND INFLATED TO INTERRUPT BLOOD FLOW DURING REMOVAL OF THE LARGE DIAMETER TAVI SHEATH. HOWEVER, ONE PATIENT IN THE RADIAL CT GROUP HAD A ILIAC RUPTURE AND REQUIRED COVERED STENT IMPLANTATION AND NECESSITATING CONVERSION TO CONTRALATERAL FEMORAL ACCESS FOR THE RADIAL PATIENT. IN RADIAL CT, PATIENTS WHO REQUIRED COVERED STENT IMPLANTATION FOR VASCULAR COMPLICATIONS, AN OTW BALLOON WAS INFLATED FROM THE RADIAL SITE TO PREVENT CATASTROPHIC THERAPEUTIC ACCESS SITE BLEEDING AND TO ALLOW TIME TO ACHIEVE CONTRALATERAL FEMORAL ACCESS AND CROSSOVER FOR STENT DEPLOYMENT. IN THESE SCENARIOS, OTW BALLOON INFLATIONS FROM THE RADIAL SITE WERE INSTRUMENTAL IN ACHIEVING GOOD FINAL OUTCOMES. WHEN ASKING FOR ADDITIONAL INFORMATION REGARDING THIS EVENT, THE SURGEON REFERRED THAT THE EVENTS REPORTED IN THE LITERATURE ARE NOT CORRELATED TO THE DEVICE CORDIS (MULTIPURPOSE CATHETER CORDIS). THE EVENTS DESCRIBED ARE PART OF THE ADVERSE EVENTS CORRELATED AT THE CLINIC PRACTICE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER PROVIDED. VESSEL DAMAGE, SUCH AS A VESSEL RUPTURE/PERFORATION, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY PROCEDURE IN WHICH MULTIPLE DEVICES ARE INTRODUCED INTO THE PATIENT. IN THIS PARTICULAR CASE, THE PATIENT HAD A LARGE DIAMETER TAVI SHEATH PLACEMENT, INTRODUCTION OF STIFF GUIDEWIRES, BALLOONS, AND CATHETERS, AS WELL AS A DEVICE TO PERFORM A TRANSCATHETER AORTIC VALVE IMPLANTATION. ANY OF THESE DEVICES COULD HAVE LED TO THE ILIAC RUPTURE THAT WAS MENTIONED IN THIS ARTICLE. HOWEVER, SINCE THE ARTICLE DOES NOT GO INTO DETAIL ON HOW OR WHEN DURING THE PROCEDURE THIS ILIAC RUPTURE OCCURRED, IT IS UNKNOWN IF THE CORDIS MULTIPURPOSE CATHETER CAUSED OR CONTRIBUTED TO THE INJURY. IN THE REQUEST FOR ADDITIONAL INFORMATION, THE SURGEON REFERENCED IN THE ARTICLE STATED THAT THE EVENTS REPORTED IN THE LITERATURE ARE NOT CORRELATED TO THE CORDIS MULTIPURPOSE CATHETER, BUT TO THE CLINICAL PRACTICE. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE EVENT MAY HAVE BEEN INFLUENCED BY VESSEL CHARACTERISTICS AND PROCEDURAL/HANDLING FACTORS. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. WITHOUT RETURN OF THE DEVICE, A LOT NUMBER, OR PROCEDURAL FILMS, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS A DESIGN OR MANUFACTURING RELATED ISSUE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY CURRAN ET AL A COMPARISON OF THE FEMORAL AND RADIAL CROSSOVER TECHNIQUES FOR VASCULAR ACCESS MANAGEMENT IN TRANSCATHETER AORTIC VALVE IMPLANTATION: THE MILAN EXPERIENCE, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 83 (2014) 156-161; ONE PATIENT IN THE RADIAL CROSSOVER GROUP REQUIRED COVERED STENT IMPLANTATION FOR ILIAC RUPTURE, NECESSITATING CONVERSION TO CONTRALATERAL FEMORAL ACCESS. ACCORDING TO THE ARTICLE, A STUDY WAS CONDUCTED TO COMPARE PATIENT OUTCOMES BASED ON TWO TECHNIQUES USED TO FACILITATE SAFE THERAPEUTIC VASCULAR ACCESS CLOSURE CALLED THE CROSSOVER TECHNIQUE (CT) UTILIZING THE CONTRALATERAL FEMORAL ARTERY OR RADIAL ARTERY. DURING THE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A CORDIS STANDARD 120-CM MULTIPURPOSE CATHETER WAS ADVANCED INTO THE ILIAC ARTERY OF THE THERAPEUTIC ACCESS SITE OVER A STANDARD 0.035-INCH DIAGNOSTIC EXCHANGE LENGTH WIRE. THE MULTIPURPOSE CATHETER FACILITATES BOTH PLACEMENT OF A 0.018 INCH NON-CORDIS ANGIOPLASTY GUIDEWIRE INTO THE DISTAL FEMORAL ARTERY AND FEMORAL ANGIOGRAPHY PRECEDING INSERTION OF THE LARGE TAVI INTRODUCER SHEATH. AFTER THE VALVE DEPLOYMENT, A NON-CORDIS OTW BALLOON IS ADVANCED TO THE THERAPEUTIC ACCESS SITE IN THE FEMORAL ARTERY, AND INFLATED TO INTERRUPT BLOOD FLOW DURING REMOVAL OF THE LARGE DIAMETER TAVI SHEATH. HOWEVER, ONE PATIENT IN THE RADIAL CT GROUP HAD A ILIAC RUPTURE AND REQUIRED COVERED STENT IMPLANTATION AND NECESSITATING CONVERSION TO CONTRALATERAL FEMORAL ACCESS FOR THE RADIAL PATIENT. IN RADIAL CT, PATIENTS WHO REQUIRED COVERED STENT IMPLANTATION FOR VASCULAR COMPLICATIONS, AN OTW BALLOON WAS INFLATED FROM THE RADIAL SITE TO PREVENT CATASTROPHIC THERAPEUTIC ACCESS SITE BLEEDING AND TO ALLOW TIME TO ACHIEVE CONTRALATERAL FEMORAL ACCESS AND CROSSOVER FOR STENT DEPLOYMENT. IN THESE SCENARIOS, OTW BALLOON INFLATIONS FROM THE RADIAL SITE WERE INSTRUMENTAL IN ACHIEVING GOOD FINAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164157 DIAGNOSTIC CARDIOLOGY CATHETER- 6F DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R| S