BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER UNK GUIDE CATHETER

    MDR report key: 13288356 · Received January 19, 2022

    Report

    Report Number
    1220452-2022-00009
    Event Type
    Injury
    Date Received
    January 19, 2022
    Date of Event
    June 3, 2021
    Report Date
    March 22, 2022
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K132673
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL ARTICLE: IT'S A TRAP: A CASE OF STRANGULATED CORONARY GUIDEWIRE AND LONGITUDINAL STENT DEFORMATION IN THE RIGHT CORONARY ARTERY YEAR: 2021 REF: DOI: 10.12659/AJCR.931058. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    AN ARTICLE TITLED: IT¿S A TRAP: A CASE OF STRANGULATED CORONARY GUIDEWIRE AND LONGITUDINAL STENT DEFORMATION IN THE RIGHT CORONARY ARTERY WAS SUBMITTED FOR REVIEW. THE ARTICLE REPORTS A CASE STUDY OF A PATIENT THAT UNDERWENT A ROUTINE PCI PROCEDURE OF THE RIGHT CORONARY ARTERY. CORONARY ANGIOGRAM SHOWED A CRITICAL BIFURCATION DISEASE IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) INVOLVING THE OSTIUM OF THE FIRST MAJOR OBTUSE MARGINAL (OM) BRANCH AND MULTIPLE MODERATE LESIONS THROUGH THE COURSE OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A LARGE DOMINANT RCA WAS TOTALLY OCCLUDED FROM MIDCOURSE. CARDIAC CATHETERIZATION WAS THEN PLANNED USING A 6 FR JUDKINS RIGHT LAUNCHER GUIDE CATHETER TO CANNULATE THE RCA. A NON-MEDTRONIC GUIDEWIRE WAS USED TO CROSS THE LESION AND THE LESION WAS PREDILATED WITH A NON-MEDTRONIC 2×15 MM SEMI-COMPLIANT BALLOON. THIS REVEALED A CRITICAL RCA WITH DIFFUSE DISEASE THROUGHOUT THE PROXIMAL TO MIDCOURSE AND AN INTERMEDIATE LESION DISTALLY, EXTENDING TO THE POSTERIOR LEFT VENTRICULAR (PLV) AND POSTERIOR DESCENDING ARTERY (PDA). A NON-MEDTRONIC 3.25×48 MM STENT WAS DEPLOYED FROM THE PROXIMAL COURSE TO A HEALTHY SEGMENT IN MID-COURSE. AFTER POST-DILATION WITH A NON-MEDTRONIC NC BALLOON THE DISEASE AT THE DISTAL EDGE OF THE STENT BECAME PROMINENT, SO A SECOND NON MEDTRONIC STENT WAS OVERLAPPED AT THE DISTAL RCA AFTER SECURING THE PLV WITH A NON-MEDTRONIC GUIDEWIRE AND PDA WITH A NEW NON MEDTRONIC GUIDEWIRE. AFTER THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE ONE NON MEDTRONIC GUIDEWIRE, WHICH WAS JAILED BETWEEN THE PROXIMAL AND DISTAL STENTS. ALL ATTEMPTED MANEUVERS WITH ANGIOPLASTY BALLOONS OR MICROCATHETER WERE UNSUCCESSFUL IN RETRIEVING THE WIRE. A SNARE WAS NOT USED DURING RETRIEVAL THIS TIME, BUT A MICRO-SNARE WAS PASSED DOWN THE GUIDEWIRE INTO THE CORONARY ARTERY TO THE LOCATION WHERE THE WIRE WAS TRAPPED AND THIS GREATLY ENHANCED THE TRACTION FORCE APPLIED ON THE WIRE AT THE POINT OF JAILING. WHILE PULLING THE WIRE, THE LAUNCHER CATHETER TIP HIT THE STENT PROXIMALLY AND DISRUPTED ITS PROFILE, PRODUCING A LONGITUDINAL DEFORMATION. SERIAL SMALL BALLOON INFLATIONS WERE PERFORMED TO CORRECT THE LONGITUDINAL STENT DEFORMATION, BUT IT FAILED TO ALIGN THE STRUTS WITH THE VESSEL LUMEN. ALTHOUGH THE PATIENT WAS PAIN-FREE AND HEMODYNAMICALLY STABLE, THE HEART TEAM DECIDED TO MOVE THE PATIENT FOR AN EMERGENT CORONARY ARTERY BYPASS OPERATION. AFTER EXPOSING THE CORONARIES, THE STENTS ALONG WITH THE GUIDEWIRE WERE REMOVED BY ARTERIOTOMY OF THE RCA. NO POSTOPERATIVE COMPLICATIONS WERE OBSERVED AND THE PATIENT WAS DISCHARGED AFTER 4 DAYS. IT WAS SUGGESTED THAT WHILE MANIPULATING EQUIPMENT, A GUIDE CATHETER SHOULD BE SUFFICIENTLY PARKED TO MINIMIZE THE ROCKING MOVEMENT INTO THE CORONARY OSTIA. EXCESSIVE MANIPULATION CAN CAUSE TRACKING OF THE CATHETERS INTO THE ARTERY AND IT CAN DISSECT OR RUPTURE THE VESSEL LUMEN AND DEFORM STENTS IN THEIR WAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051444 LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention