BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3833923 · Received May 27, 2014

    Report

    Report Number
    2024168-2014-03352
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: PROWATER 180; 300 CM UNSPECIFIED; GUIDE CATH: PIGTAIL JR4 6 FR X2; SHEATH: 8 FR BRIGHT TIP; VESSEL CLOSURE: PERCLOSE; IMPELA. (B)(4) - ABOVE RATED BURST PRESSURE (RBP). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES OR EXCEPTIONS FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. IT SHOULD BE NOTED THE TREK/ MINI TREK INSTRUCTIONS FOR USE (IFU) STATES THAT BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AS STEMI AND WAS TRANSFERRED FROM ANOTHER HOSPITAL WITH AN INTRAAORTA BALLOON PUMP AND THROMBOSIS. THE BALLOON PUMP WAS REMOVED AND THE LEFT GROIN ACCESS SITE WAS CLOSED USING A PERCLOSE DEVICE WITHOUT ISSUE. THE RIGHT GROIN WAS ACCESSED AND USING A JR4 6 FR GUIDE CATHETER AND A PROWATER GUIDE WIRE FOR THE PROCEDURE OF THE NON-TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA), THE 2.0 X 20 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND WAS INFLATED/DEFLATED 5 TIMES WITHOUT ISSUE AND REMOVED. THE 3.0 X 20 MM RX TREK BDC WAS ADVANCED AND POSITIONED AND INFLATED/DEFLATED 4 TIMES AT 10 ATMOSPHERE (ATM) FOR 3 SECONDS, 14 ATM FOR 6 SECONDS, 16 ATM AT 5 SECONDS, AND 16 ATM FOR 6 SECONDS. THE BDC WAS REMOVED FROM THE ANATOMY WITHOUT NOTED RESISTANCE, HOWEVER, SHAFT SEPARATION OCCURRED AND UNDER FLUOROSCOPY IT WAS NOTED THE BALLOON MARKERS WERE VISIBLE AND REMAINED ON THE GUIDE WIRE IN THE PROXIMAL RCA. USING A 2.0 X 15 MM RX TREK BDC AT LOW PRESSURE INFLATION THE BALLOON FRAGMENT WAS PINNED ON THE GUIDE WIRE; THE FRAGMENT, BDC, GUIDE WIRE AND GUIDE CATHETER WERE REMOVED AS A SYSTEM FROM THE ANATOMY WITHOUT ISSUE. THE VESSEL WAS REWIRED WITH A PROWATER GUIDE WIRE AND A JR4 GUIDE CATHETER AND THE PROCEDURE PROCEEDED USING A NON-ABBOTT ASPIRATION CATHETER, MULTIPLE NON-ABBOTT BDC AND INFLATION/DEFLATIONS WITHOUT ISSUE FOLLOWED BY MULTIPLE ASPIRATIONS WITH NON-ABBOTT THROMBECTOMY DEVICES. THE PATIENT OUTCOME WAS STABLE AND SATISFACTORY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311565 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40219G1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention