BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 16976432 · Received May 22, 2023

    Report

    Report Number
    2030404-2023-00032
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Report Date
    June 15, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DEVICE ENTRAPMENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE 2214-0271/© 2022 HEART RHYTHM SOCIETY. PUBLISHED BY ELSEVIER INC. IN AN ARTICLE TITLED "CORONARY SINUS SPASM WITH CATHETER ENTRAPMENT AND ADJACENT CORONARY ARTERY COMPRESSION DURING AN ABLATION PROCEDURE IN A CHILD". 2022-08-01, VOLUME 38, ISSUE 8, PAGES 1277-1285, COPYRIGHT © 2022 CANADIAN CARDIOVASCULAR SOCIETY, CHRISTOPHE VO. A 6-YEAR-OLD GIRL WEIGHING 39.7 KG WAS REFERRED FOR CATHETER ABLATION IN THE SETTING OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA, A STRUCTURALLY NORMAL HEART, AND NO VENTRICULAR PREEXCITATION. SUPRAVENTRICULAR TACHYCARDIA WAS FIRST DOCUMENTED AT 2 YEARS OF AGE, WITH FREQUENT RECURRENT BOUTS DESPITE ANTIARRHYTHMIC DRUG THERAPY. EPISODES OFTEN TERMINATED WITH VAGAL MANEUVERS BUT OCCASIONALLY REQUIRED INTRAVENOUS ADENOSINE. THE CATHETER TIP BECAME ENTRAPPED IN THE PROXIMAL CORONARY SINUS AT OR NEAR THE OSTIUM OF THE MIDDLE CARDIAC VEIN. EFFORTS TO REPOSITION OR RETRACT THE CATHETER USING GENTLE TRACTION WERE FUTILE. A DEFLECTABLE SHEATH (6.5F DESTINO TWIST; OSCOR, PALM HARBOR, FL) WAS INTRODUCED IN ORDER TO CANNULATE THE CORONARY SINUS FOR ANGIOGRAPHY. ATTEMPTS WERE UNSUCCESSFUL WITH AND WITHOUT GUIDANCE BY A SECOND 4F STEERABLE DECAPOLAR CATHETER WITHIN THE SHEATH. THE HANDLE OF THE ENTRAPPED DECAPOLAR CATHETER WAS REMOVED BY CUTTING THROUGH THE SHAFT TO ALLOW A 5F SHEATH (PERFORMER GUIDING SHEATH; COOK MEDICAL, BLOOMINGTON, IN) TO BE POSITIONED OVER THE CATHETER AND INTO THE CORONARY SINUS. CONTRAST INJECTION THROUGH THIS SHEATH REVEALED COMPLETE OBSTRUCTION OF THE PROXIMAL CORONARY SINUS AT THE TIP OF THE ENTRAPPED CATHETER, PRESUMABLY OWING TO SPASM (FIGURE 1). SELECTIVE CORONARY ANGIOGRAPHY SHOWED SEVERE NARROWING OF THE CIRCUMFLEX ARTERY ADJACENT TO THE SITE OF OBSTRUCTION (FIGURE 1C). THE PATIENT REMAINED WITHOUT ISCHEMIC CHANGES ON 12-LEAD ELECTROCARDIOGRAMS. THE CARDIAC SURGICAL TEAM WAS CONTACTED FOR ONSITE SURGICAL BACKUP AND READINESS. THE SHEATH WAS ADVANCED NEAR THE TIP OF THE ENTRAPPED CATHETER. CAREFUL TRACTION WITH COUNTERTRACTION MANEUVERS FAILED TO RELEASE THE CATHETER. NITROGLYCERIN (2.5 MCG/KG) WAS ADMINISTERED THROUGH THE LONG SHEATH IN THE CORONARY SINUS WHILE APPLYING TRACTION AND COUNTERTRACTION. THE CORONARY SINUS SPASM SUBSIDED WITHIN 5 MINUTES AND THE DECAPOLAR CATHETER WAS FREED. ON INSPECTION, NO TISSUE WAS ADHERENT TO THE TIP OF THE RETRIEVED CATHETER. REPEAT CORONARY ANGIOGRAPHY SHOWED RESTORATION OF UNIMPEDED FLOW TO THE CIRCUMFLEX ARTERY, NORMAL VENOUS RETURN VIA THE CORONARY SINUS, AND NO EVIDENCE OF CORONARY SINUS DISSECTION (FIGURE 2). NO PERICARDIAL EFFUSION WAS NOTED BY ¿QUICK-LOOK¿ TRANSTHORACIC ECHOCARDIOGRAPHY. THE ELECTROPHYSIOLOGICAL STUDY WAS RESUMED WITHOUT A DIAGNOSTIC CATHETER PLACED IN THE CORONARY SINUS. ORTHODROMIC ATRIOVENTRICULAR REENTRANT TACHYCARDIA VIA A CONCEALED LEFT LATERAL ACCESSORY PATHWAY WAS DIAGNOSED. THE ACCESSORY PATHWAY WAS SUCCESSFULLY ABLATED BY MEANS OF A RETROGRADE AORTIC APPROACH (FIGURE 3), AS PER STANDARD LOCAL PRACTICE. THROUGHOUT, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WITHOUT ISCHEMIC ELECTROCARDIOGRAPHIC CHANGES. POSTPROCEDURAL TRANSTHORACIC ECHOCARDIOGRAPHY WAS UNREMARKABLE, WITH NO PERICARDIAL EFFUSION OR REGIONAL WALL MOTION ABNORMALITY. THE PATIENT RECEIVED AN INTRAVENOUS PERFUSION OF HEPARIN OVERNIGHT IN ACCORDANCE WITH THE INSTITUTIONAL PROTOCOL FOR LEFT-SIDED ABLATION PROCEDURES. SHE HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED FROM HOSPITAL THE FOLLOWING DAY WITH A 1-MONTH PRESCRIPTION OF ASPIRIN (80 MG DAILY). AT 3 MONTHS OF FOLLOW-UP, SHE REMAINS ARRHYTHMIA-FREE OFF ANTIARRHYTHMIC DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780266 INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, INC. IBI-81531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown