BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1023384 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00944
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION LETTERKENNY
    Product Code
    LIT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON DILATATION PROCEDURE, A BALLOON RUPTURE AND VESSEL DISSECTION OCCURRED. THE HIGHLY STENOSED LESION WAS LOCATED IN THE BRACHIOCEPHALIC ARTERIOVENOUS FISTULA. THE PHYSICIAN WAS USING THE PERIPHERAL CUTTING BALLOON IN AN ATTEMPT TO DILATE THE "TIGHT" FISTULA. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED "AT THE SAME TIME AS THE VESSEL." THE NUMBER OF ATMS REACHED DURING EACH INFLATION IS UNK. THE VESSEL DISSECTION REPAIRED ITSELF WITH NO HARM TO THE PT. IN THE OPINION OF THE PHYSICIAN, THE STENOSIS MAY HAVE BEEN CONTRIBUTORY TO THE RUPTURE AND SUBSEQUENT DISSECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PT INJURIES OR COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION LETTERKENNY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other