BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 10871500 · Received November 19, 2020

    Report

    Report Number
    2024168-2020-09765
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    November 2, 2020
    Report Date
    February 9, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648138164
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL, FUNCTIONAL AND SEM INSPECTIONS/ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED BALLOON RUPTURE AND INFLATION ISSUE WERE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED ONE MANUFACTURING NONCONFORMITY ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE REPORTED PATIENT EFFECTS OF AIR EMBOLISM AND ANGINA ARE LISTED IN THE CORONARY DILATATION CATHETERS (CDC), TREK RX AND MINI TREK RX, GLOBAL, INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS. THE BALLOON WAS ULTIMATELY SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. THE SEM REPORT DETERMINED THE BALLOON AND INNER MEMBER FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LEAK AND ADJACENT AREA APPEARED PINCHED. THE INVESTIGATION DETERMINED THE REPORTED BALLOON RUPTURE AND INFLATION ISSUE APPEAR TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF AIR EMBOLISM, ANGINA AND EKG/ECG CHANGES AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENT WITH MEDICATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2X20MM MINI TREK BALLOON WAS PREPARED ACCORDING TO ROUTINE. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES AND ONLY PARTIALLY INFLATED BUT WAS NOTED TO BE LOSING PRESSURE. DURING THIS IT WAS NOTED THAT THE PATIENT THEN DEVELOPED SEVERE CHEST PAIN FOR APPROXIMATELY 10 MINUTES. SIMULTANEOUSLY, ST ELEVATION WAS ALSO NOTED. DURING AN X-RAY SEVERAL MICRO-BUBBLES OF AIR WERE NOTED ENTERING THE CORONARY VESSEL WHICH WAS CONFIRMED TO BE AN AIR EMBOLISM. IT WAS NOTED THAT THE AIR EMBOLISM ULTIMATELY DISAPPEARED AND WAS NOT TREATED. THE CHEST PAIN AND ST ELEVATION WAS TREATED VIA MEDICATION. THE BALLOON WAS REMOVED AND AFTER CONTROL INFLATION, LEAKAGE WAS NOTED FROM COMING FROM THE BALLOON ITSELF. THE PATIENT FELT DISCOMFORT FOR APPROXIMATELY 10 MINUTES, BUT ULTIMATELY FELT RECOVERED AFTER THE PROCEDURE. ALTHOUGH THE PROCEDURE WAS PROLONGED FOR ABOUT 5 MINUTES, THERE WAS NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY NOTED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336781 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012270-20 00122G1 08717648138164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention