BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2042141 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02410
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CATHETER WAS RETURNED WITH BLOOD VISIBLE ON THE LOOSELY-FOLDED BALLOON AND IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE WITHIN THE BODY. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED FROM A PINHOLE IN THE BALLOON ABOVE THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. SCANNING ELECTRON MICROSCOPY (SEM) CONCLUDED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LEAK APPEARED TO BE LOCATED ALONG A BALLOON FOLD/CREASE ON THE OUTER SURFACE. THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. HOWEVER, IT IS POSSIBLE THAT THE BALLOON WAS DAMAGED DURING MANUFACTURING SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED AND MAY HAVE AIDED THE INVESTIGATION. THE REPORTED PATIENT EFFECT OF EMBOLISM, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ANGIOPLASTY PROCEDURES AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE ALONG THE FOLD AND DAMAGE NOTED COULD NOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOYAGER NC WAS PREPPED AND USED FOR POST-DILATATION OF A NON-ABBOTT STENT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHEN THE BALLOON WAS POSITIONED, AND INFLATED TO 4 ATMOSPHERES, CONTRAST WAS NOTED DISTAL TO THE STENT. THE VOYAGER WAS REMOVED, AND A VIEW OF THE VESSEL WAS TAKEN. IT WAS NOTED THAT A SMALL AMOUNT OF AIR WAS NOTED DISTAL; THEREFORE, THE LAD WAS FLUSHED, AND THE AIR WAS REMOVED. A NEW BALLOON WAS USED TO SUCCESSFULLY POST-DILATE THE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0120862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention