BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2223735 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05945
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: ANALYSIS OF THE CATHETER NOTED CONTRAST VISIBLE IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE BALLOON INFLATED. FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY DEFLATING THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED THUS BLOCKING THE FLOW OF CONTRAST, DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. TO HELP ENSURE THAT THE REPORTED DIFFICULTIES ARE NOT DUE TO MANUFACTURING, 100% OF THE PRODUCTS ARE LEAK TESTED AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY DEFLATION TIMES. THE TOTAL CATHETER LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR WAS FILLED WITH CONTRAST MEDIUM; DILUTED 1:1 WITH COLORED WATER AND WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP). THE BALLOON INFLATED TO RBP WITH NO ANOMALIES NOTED. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS THE DEFLATION TIMES OF THE BALLOON WERE MEASURED AND MET MANUFACTURING CRITERIA. IT IS POSSIBLE THE BALLOON INTERACTED WITH THE DEPLOYED STENT, CONTRIBUTING TO THE DEFLATION DIFFICULTIES; HOWEVER, THIS COULD NOT BE CONFIRMED. IT WAS REPORTED THAT AS THE BALLOON DID NOT DEFLATE, THE PATIENT EXPERIENCED CHEST PAIN AND ST ELEVATION. ANGINA IS A KNOWN ADVERSE EVENT AS LISTED IN THE VOYAGER NC INSTRUCTIONS FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED NO RELATED INCIDENTS; THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE BALLOON WAS NOT SOAKED PRIOR TO USE. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IT DOES NOT APPEAR THAT THE FAILURE TO SOAK THE BALLOON CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY, A 3.5X38 XIENCE PRIME STENT WAS SUCCESSFULLY DEPLOYED. POST DILATATION OF THE PROXIMAL SEGMENT OF THE STENT WAS PERFORMED USING A 3.75X12 VOYAGER NC DILATATION CATHETER AT 18 ATMOSPHERES. INDEFLATOR PRESSURE WAS REVERSED; HOWEVER, THE BALLOON DID NOT DEFLATE. THE PHYSICIAN WAITED FOR APPROXIMATELY 30 SECONDS BUT THE BALLOON DID NOT DEFLATE. THE PATIENT DEVELOPED CHEST PAIN AND ST ELEVATION. IN AN EFFORT TO PREVENT CHEST PAIN AND ST ELEVATION FROM INCREASING, THE PHYSICIAN PULLED THE BALLOON AND THE GUIDE CATHETER AS A SINGLE UNIT FROM THE ARTERY AND THEN PULLED THE BALLOON BACK INSIDE THE GUIDE CATHETER TO REMOVE IT FROM THE ANATOMY. THE PATIENT DID NOT EXPERIENCE ANY FURTHER ST ELEVATION OR CHEST PAIN. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL REPORTED INFORMATION INDICATES THAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WAS MILDLY CALCIFIED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE VOYAGER DILATATION CATHETER; HOWEVER, RESISTANCE WAS FELT DURING REMOVAL. WHEN THE DILATATION CATHETER WAS REMOVED FROM THE ANATOMY, IT WAS NOTED THAT THE BALLOON WAS PARTIALLY INFLATED. MYOCARDIAL INFARCTION WAS NOT DIAGNOSED AND THE ST ELEVATIONS RESOLVED IMMEDIATELY ONCE THE BALLOON WAS REMOVED FROM THE ANATOMY. THERE WAS A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. REPORTEDLY, THE DILATATION CATHETER WAS NOT PREPARED PRIOR TO USE PER THE INSTRUCTIONS FOR USE. POST DILATATION OF THE XIENCE PRIME WAS PERFORMED AS STANDARD PROCEDURE. 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 1030561

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other STENT: XIENCE PRIME