BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER UNK GUIDE CATHETER

    MDR report key: 12323530 · Received August 16, 2021

    Report

    Report Number
    1220452-2021-00036
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    January 1, 2012
    Report Date
    October 26, 2021
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K132673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADD FDC CODES 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.

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: FAILURE OF A BALLOON TO DEFLATE DURING POST DILATATION IN A CORONARY ARTERY AUTHORS: TAKURO TAKAMA, YOSHIAKI ITO, HIROSHI ISHIMORI, REIKO TSUKAHARA, TOSHIYA MURAMATSU JOURNAL: CARDIOVASC INTERV AND THER YEAR: 2015 REFERENCE: DOI 10.1007/S12928-014-0249-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE TITLED - FAILURE OF A BALLOON TO DEFLATE DURING POST DILATATION IN A CORONARY ARTERY - WAS SUBMITTED FOR REVIEW. THIS ARTICLE IS A CASE STUDY INVOLVING A PATIENT WHO PRESENTED TO HOSPITAL WITH CHEST PAIN ON EXERCISE. A CORONARY ANGIOGRAPHY (CAG) SHOWED SEVERE STENOSIS AT THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND AT THE BIFURCATION OF THE FIRST DIAGONAL BRANCH (D1). A MEDTRONIC 6FR LAUNCHER GUIDE CATHETER WAS PLACED VIA THE RIGHT RADIAL ARTERY. A NON-MDT DRUG ELUTING STENT (DES) WAS DEPLOYED TO THE DISTAL LAD AT 10 ATM, FOLLOWED BY A NON MDT DES DEPLOYED TO THE PROXIMAL LAD AT 10 ATM. AFTER STENT IMPLANTATION, CAG SHOWED SUCCESSFUL DILATION OF THE LESION, BUT PROGRESSION OF THE D1 STENOSIS. IT WAS DECIDED TO TREAT THE D1 LESION WITH BALLOON ANGIOPLASTY AND TO USE THE KISSING BALLOON TECHNIQUE (KBT) TO SIMULTANEOUSLY TREAT THE D1 AND LAD LESIONS. A 2.25 X 12 MM AND 3.0 X 15 MM NC BALLOONS WERE INTRODUCED INTO THE D1 AND LAD, RESPECTIVELY. THE D1 BALLOON WAS INFLATED AT 18 ATM, FOLLOWED BY INFLATION OF THE BALLOON IN THE LAD AT 14 ATM. HOWEVER, THE KBT COULD NOT BE DONE AS PLANNED AS THE LAD BALLOON FAILED TO DEFLATE. THE ECG IMMEDIATELY SHOWED ST-SEGMENT ELEVATION AND THE PATIENT BEGAN TO COMPLAIN OF CHEST PAIN. MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFUL. THE 6FR LAUNCHER GUIDE CATHETER WAS DEEPLY ENGAGED BY ANCHORING TO THE BALLOON. THEN ALL SYSTEMS WERE PULLED BACK, INCLUDING THE GUIDING CATHETER, BALLOON, AND GUIDEWIRE, ALLOWING THE BALLOON TO BE RETRIEVED FROM THE CORONARY VESSELS DESPITE CONSIDERABLE RESISTANCE. HOWEVER, THE BALLOON REMAINED INFLATED IN THE ASCENDING AORTA, MAKING IT ALMOST IMPOSSIBLE TO WITHDRAW INTO THE GUIDING CATHETER. THE REVERSE SLIP-THROUGH TECHNIQUE WAS USED TO RETRIEVE THE BALLOON. A NEW NORMAL BALLOON WAS PLACED PARALLEL TO THE DEFECTIVE BALLOON AND INFLATED AT THE EDGE OF THE GUIDING CATHETER. AS BOTH BALLOONS WERE PULLED TOWARD THE GUIDING CATHETER, THE NORMAL BALLOON WAS DEFLATED. AFTER REINFLATION OF THE NORMAL BALLOON, THE SAME PROCEDURE WAS REPEATED SEVERAL TIMES, RESULTING IN THE DEFECTIVE BALLOON BEING SUCCESSFULLY DRAWN BACK INTO THE GUIDING CATHETER. THE LAD AND D1 LESIONS WERE SUBSEQUENTLY RETREATED BY THE KBT. POST-PCI CAG SHOWED NO CORONARY ARTERY RUPTURE OR DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224202 LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention