BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI PTA BALLOON CATHETER

    MDR report key: 1901870 · Received November 17, 2010

    Report

    Report Number
    9610978-2010-00243
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 26, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAXI LD BALLOON RUPTURED AND GOT STUCK IN THE VEIN DURING TREATMENT OF A HIGHLY RESISTANT, >70% CALCIFIED, FIBROTIC STENOSIS IN THE NON-TORTUOUS LEFT MID BRACHIAL CEPHALIC VEIN. THE PATIENT WAS SENT FOR SURGERY FOR REMOVAL OF THE BALLOON; THE VASCULAR SURGEON CONFIRMED THAT THE BALLOON RUPTURED IN A TRANSVERSE MANNER. THE BALLOON WAS INFLATED MORE THAN TWO TIMES. THE PHYSICIAN COULD NOT RECALL WHAT THE MAXIMUM INFLATION PRESSURE WAS DURING EACH INFLATION OR WHEN THE BALLOON BURST. HE DID NOT LOOK AT THE PRESSURE GAUGE. THE BALLOON WAS NOT CAUGHT IN A DEPLOYED STENT. THERE WAS NO STENT DEPLOYED, BUT THE STENOSIS OPENED SLIGHTLY; THERE WAS APPROXIMATELY A 50% RESIDUAL STENOSIS. THE BALLOON RUPTURED AND INVERTED. THEY COULD NOT TELL WHERE THE PIECE SEPARATED. THE PATIENT IS STABLE. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED ON THE PRODUCT PRIOR TO USE. THE DEVICE WAS INSERTED THROUGH A 7F SHEATH. THE BALLOON WAS DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. LEAK AND BURST TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THIS LOT. NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ALTHOUGH WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE, BASED ON THE AVAILABLE INFORMATION PROCEDURAL FACTORS AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT A PHYSICIAN REPORTED A MAXI LD BALLOON RUPTURED AND GOT STUCK IN THE VEIN. THE PATIENT WAS SENT FOR SURGERY AND THE VASCULAR SURGEON CONFIRMED THAT THE BALLOON RUPTURED IN A TRANSVERSE MANNER. THE BALLOON WAS INFLATED MORE THAN TWO TIMES. THE PHYSICIAN COULD NOT RECALL WHAT THE MAXIMUM INFLATION PRESSURE WAS DURING EACH INFLATION OR WHEN THE BALLOON BURST. HE DID NOT LOOK AT THE PRESSURE GAUGE. THE BALLOON WAS NOT CAUGHT IN A DEPLOYED STENT. THERE WAS NO STENT DEPLOYED, BUT THE STENOSIS OPENED SLIGHTLY. THERE WAS ABOUT 50% RESIDUAL STENOSIS. THE BALLOON RUPTURED AND INVERTED. THEY COULD NOT TELL WHERE THE PIECE SEPARATED. THE PATIENT WAS SENT FOR OPEN SURGERY TO REMOVE THE BALLOON. THE PATIENT IS STABLE. THE TARGET LESION WAS A >70% STENOSIS IN THE LEFT MID BRACHIAL CEPHALIC VEIN. IT WAS A HIGHLY RESISTANT CENTRAL VEIN STENOSIS. THE LESION WAS CALCIFIED, BUT NOT FIBROTIC. THERE WAS NO VESSEL TORTUOSITY OR ANGULATION. THE BALLOON WAS DISCARDED. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED ON THE PRODUCT PRIOR TO USE. THE DEVICE WAS INSERTED THROUGH A 7F SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15172974

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7F SHEATH OF UNKNOWN BRAND.