BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER

    MDR report key: 3913666 · Received July 3, 2014

    Report

    Report Number
    2183870-2014-00165
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K130911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL]MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN PLYMOUTH 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    EVALUATION SUMMARY:A COMPACT DISC WITH SEVERAL CINE SERIES FROM THE PROCEDURE WAS RECEIVED FOR THIS EVALUATION.THE IMAGES INCLUDE A DEVICE WITH THE APPROPRIATE MAKER BANDS FOR A 3.0MM X 210MM RAPIDCROSS CATHETER IN THE COMMON FEMORAL/ ILIAC REGION BUT THE IMAGE WAS NOT OF AN INFLATED BALLOON. TWO IMAGES DOCUMENT A SNARE-TYPE DEVICE IN THE SAME REGION BUT IT COULD NOT BE DETERMINED WHAT THE SNARE WAS CAPTURING. THERE WERE SEVERAL IMAGES OF TWO (KISSING STENTS AT THE TOP OF THE ARCH (ILIAC BIFURCATION). THERE WERE ALSO SEVERAL ANGIOGRAPHIC ASSESSMENT IMAGES/ SERIES. THE REMAINDER OF THE IMAGES DID NOT APPEAR TO BE DIRECTLY RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    LASER ATHERECTOMY WAS PERFORMED PRIOR TO TREATMENT IN THE POSTERIOR TIBIAL ARTERY. THE VESSEL HAD MULTIPLE HIGH-GRADE STENOSES. THE ACCESS VESSEL WAS THE RIGHT COMMON FEMORAL ARTERY THE PHYSICIAN WENT UP AND OVER TO PERFORM THE INTERVENTION ON LEFT POSTERIOR TIBIAL ARTERY. THE PERONEAL AND AT WERE OCCLUDED. THE PHYSICIAN USED 3MM RAPIDCROSS TO RE-DILATE VESSEL. A SMALL PIECE OF THE BALLOON SHEARED OFF AND WAS RETRIEVED WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391388 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN A14BX030210170 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention