BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY¿ STEERABLE EP CATHETER

    MDR report key: 8486465 · Received April 5, 2019

    Report

    Report Number
    2030404-2019-00017
    Event Type
    Injury
    Date Received
    April 5, 2019
    Report Date
    April 5, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION.  A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER IS UNAVAILABLE. BASED ON THE INFORMATION PROVIDED TO ABBOTT, THE REPORTED WITHDRAWAL DIFFICULTY AND SUBSEQUENT EXTENDED PROCEDURE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    AN EXTENDED PROCEDURE DUE TO WITHDRAWAL DIFFICULTY OCCURRED. THE FOLLOWING WAS PUBLISHED IN EP EUROPACE IN AN ARTICLE TITLED ¿UNTYING OF DIAGNOSTIC DECAPOLAR CATHETER KNOT USING A STEERABLE SHEATH AND ABLATION CATHETER " BY PLASEK, J, PEICHL, P AND KAUTZNER, J. JULY 2018. "A (B)(6) MAN UNDERWENT ELECTROPHYSIOLOGY STUDY FOR TYPICAL RIGHT ATRIAL FLUTTER. A DECAPOLAR DIAGNOSTIC CATHETER (INQUIRY TM, IRVINE BIOMEDICAL/ ST. JUDE MEDICAL COMPANY, IRVINE, CA, USA) WAS PLANNED TO BE ADVANCED INTO THE CORONARY SINUS VIA A 7 FR SHEATH IN THE FEMORAL VEIN. INITIALLY, MANIPULATION AND ROTATION WITH THE CATHETER WAS PERFORMED WITHOUT FLUOROSCOPIC GUIDANCE. WHEN FLUOROSCOPY WAS USED, IT REVEALED A HELICAL-SHAPED, KNOT-LIKE STRUCTURE WITH A TIP OF THE CATHETER POINTING CRANIALLY (DECAPOLAR CATHETER STACKED IN THE PELVIC VEINS). GENTLE TRACTION OR ROTATION DID NOT ALLOW CATHETER WITHDRAWAL. QUITE THE OPPOSITE¿BY PULLING THE CATHETER THE ¿FALSE-KNOT¿ TIGHTENED AND MADE CATHETER RETRACTION FROM FEMORAL VEIN IMPOSSIBLE. TO SOLVE THE PROBLEM, A STEERABLE AGILIS TM NXT SHEATH (8.5 FR/ 91 CM, ST. JUDE MEDICAL, MINNETONKA, MINNEAPOLIS, MN, USA) WITH AN 8-MM ABLATION CATHETER ALCATH FLUTTER BLACK LT G (BIOTRONIK, BERLIN, GERMANY) WAS ADVANCED INTO THE RIGHT ATRIUM FROM THE RIGHT INTERNAL JUGULAR VEIN. THIS ASSEMBLY WAS SELECTED TO IMPROVE TRACTION CAPABILITY OF THE ABLATION CATHETER. PUSHING THE DECAPOLAR CATHETER UPWARDS, THE TIP OF THE DECAPOLAR CATHETER REMAINED STACKED IN THE PELVIC VEINS, WHILE THE BODY OF THE CATHETER FORMED A LONG LOOP REACHING TO THE RIGHT ATRIUM. THE KNOT WAS HOOKED BY THE ABLATION CATHETER AND BY GENTLE TRACTION OF THE ASSEMBLY UPWARDS, THE EYE OF THE KNOT WAS SLOWLY LOOSENED AND THE TIP OF THE ENTRAPPED DECAPOLAR CATHETER RELEASED AND MOVED UPWARDS. BY PULLING BOTH THE ASSEMBLY AND THE DECAPOLAR CATHETER AGAINST EACH OTHER, THE FALSE-KNOT IN THE PELVIC VEIN WAS COMPLETELY LOOSENED, AND THE TIP OF THE DECAPOLAR CATHETER WAS RETRACTED INTO THE RIGHT ATRIUM. AFTERWARDS, THE DECAPOLAR CATHETER WAS UNHOOKED AND PULLED BACK THROUGH THE ORIGINAL INSERTION SITE IN THE RIGHT FEMORAL VEIN. AFTER REMOVAL OF THE DECAPOLAR CATHETER, A SIGNIFICANT ¿CAMEL-LIKE¿ DOUBLE HUMP DEFORMATION WAS OBSERVED ON ITS SHAFT (RETRACTED DEFORMED DECAPOLAR CATHETER). THE STEERABLE SHEATH WAS EXCHANGED FOR AN 8-FR INTRODUCER WHICH WAS USED FOR ADVANCING ANOTHER DECAPOLAR CATHETER INTO THE CORONARY SINUS. BOTH THE DUODECAPOLAR AND ABLATION CATHETER WERE INTRODUCED VIA THE RIGHT FEMORAL VEIN (8 FR SHEATH AND SWARTZTMSR0 81 CMSHEATH) INTO THE RIGHT ATRIUM. SUBSEQUENT INTRACARDIAC ECHOCARDIOGRAPHY SHOWED NO PERICARDIAL EFFUSION OR ANOTHER INJURY TO THE HEART. THE CAVOTRICUSPID ISTHMUS WAS SUCCESSFULLY ABLATED, AND BIDIRECTIONAL BLOCK WAS CONFIRMED. THE ENTIRE PROCEDURE LASTED 115MIN WITH 20 MIN FLUOROSCOPY TIME AND RADIATION DOSE OF 2970 LG/M2, THE TIME SPEND FOR UNTYING THE CATHETER WAS 45MIN. NO APPARENT COMPLICATIONS IN THE GROIN/PELVIC REGION WAS CLINICALLY OBSERVED. THIS CASE DEMONSTRATES A NOVEL TECHNIQUE OF UNTYING KNOTTED DIAGNOSTIC CATHETER IN THE PELVIC REGION WAS CLINICALLY OBSERVED (DOI:10.1093/EUROPACE/EUY076).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281091 INQUIRY¿ STEERABLE EP CATHETER ELECTROPHYSIOLOGY (STEERABLE) DRF ST. JUDE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other