BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 6 120X30

    MDR report key: 3840476 · Received May 30, 2014

    Report

    Report Number
    2183870-2014-00119
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    PMA / PMN Number
    K130904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE TRELLIS ODU AND CATHETER WERE RECEIVED FOR EVALUATION. THE ODU DOES NOT APPEAR TO BE RELATED TO THE REPORTED EVENT. THE TWO BALLOON SYRINGES, THE INFUSION SYRINGE AND THE ASPIRATION SYRINGE WERE PRESENT AND ATTACHED TO THE TRELLIS CATHETER MANIFOLD. THE DISTAL BALLOON SYRINGE STOPCOCK WAS OPEN AND THERE WAS INFLATION MEDIA IN THE SYRINGE CHAMBER. THERE WAS COLLECTED THROMBUS IN THE ASPIRATION LUMEN AND ON THE EXTERIOR OF THE CATHETER . THE DISTAL BALLOON SYRINGE WAS COMPRESSED AND A LEAK WAS NOTED AT THE DISTAL END OF THE MANIFOLD . THE SYRINGE PLUNGE WAS PULLED BACK TO GENERATE A VACUUM IN THE SYSTEM. A LEAK CHANNEL WAS NOTED THROUGH THE MANIFOLD ADHESIVE.

    Description of Event or Problem · 1

    THE TRELLIS DEVICE WAS PREPPED. THE PHYSICIAN INFLATED THE DISTAL BALLOON AND INJECTED 1.2ML OF THE CONTRAST SALINE MIX. (3:1 SALINE/CONTRAST). THE PROXIMAL BALLOON WAS THEN INFLATED IN THE SAME FASHION. ONCE THE PHYSICIAN GAVE THE INITIAL 2CC DOSE OF TPA, HE ASKED THE FELLOW TO PAN UP TO THE DISTAL BALLOON. THERE WAS SOME STAINING OBSERVED AND THE BALLOON WAS NOT VISIBLE. AT THIS POINT, IT WAS SUSPECTED THAT THE BALLOON BURST. BOTH BALLOONS WERE DEFLATED. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON OUTSIDE THE BODY HOWEVER THE FLUID WAS SPRAYING OUT. THE PHYSICIAN THEN ABORTED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319215 TRELLIS 6 120X30 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN BVT612030 552034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other .035 GLIDEWIRE| .035 QUICKCROSS CATHETER