BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2241454 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06241
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BALLOON INFLATED AND FLUID LEAKED FROM A TEAR IN THE DISTAL END OF THE BALLOON AT THE PROXIMAL EDGE OF THE DISTAL MARKER BAND. THERE WAS A FLAP OF BALLOON MATERIAL ALONG SIDE OF THE LONGITUDINAL TEAR. FACTORS THAT CAN CONTRIBUTE TO TEARS IN THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, AND/OR THE HEAVILY CALCIFIED LESION, SUCH THAT THE BALLOON TORE UPON THE FIRST INFLATION AT THE RATED BURST PRESSURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE CATHETER NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, CONSISTENT WITH THE CATHETER ADVANCED OVER A GUIDE WIRE. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE MULTIPLE BENDS AND KINKS NOTED TO THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND BEND MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE 2/3 COLLAPSED BALLOON PROFILE WAS MEASURED AND MET MANUFACTURING CRITERIA. IT WAS REPORTED THE LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE RESISTANCE. THE BALLOON WAS SOAKED IN WARM WATER PRIOR TO INFLATION. USING A NEW INDEFLATOR FILLED WITH WATER, PRESSURIZED THE BALLOON TO THE RATED BURST PRESSURE (RBP) AND THE BALLOON DID NOT INFLATE. THE BALLOON WAS LEFT PRESSURIZED OVERNIGHT. THE BALLOON INFLATED AND FLUID LEAKED FROM A RUPTURE IN THE DISTAL END OF THE BALLOON AT THE PROXIMAL EDGE OF THE DISTAL MARKER BAND, CONFIRMING THE REPORTED RUPTURE. THERE WAS A FLAP OF BALLOON MATERIAL ALONG SIDE OF THE LONGITUDINAL RUPTURE. THE FLAP WAS .05 MM IN LENGTH. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, AND/OR THE HEAVILY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT THE RBP. ADDITIONALLY, ANALYSIS NOTED A FLAP OF TORN BALLOON MATERIAL. DAMAGE OF THIS TYPE CAN BE THE RESULT OF MATERIAL PROCESSING OR INCORRECT PREPARATION FOR USE. IT IS LIKELY THAT THE HYDROPHILIC COATING ON THE BALLOON WAS NOT SUFFICIENTLY ACTIVATED UPON EXPOSURE TO MOISTURE SUCH THAT AS THE BALLOON WAS INFLATED, THE BALLOON MATERIAL TORE AND PEELED. FURTHER, AS THE BALLOON WAS UNABLE TO PROPERLY REFOLD DUE TO THE RUPTURE, THIS WOULD CONTRIBUTE TO THE REPORTED RESISTANCE DURING RETRACTION OF THE CATHETER. 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 OTHER INCIDENTS. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED TREATMENT WAS BEING PERFORMED ON THE MID CIRCUMFLEX ARTERY THAT WAS NARROW AND HEAVILY CALCIFIED. PREPARATION OF THE DEVICE WAS PERFORMED PER THE INSTRUCTIONS FOR USE. SIGNIFICANT RESISTANCE WAS FELT DURING INSERTION OF THE DILATATION BALLOON CATHETER AND UPON INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. DURING REMOVAL OF THE DEVICE FROM THE PATIENT ANATOMY, A LITTLE BIT OF RESISTANCE WAS FELT. THE VASCULAR ACCESS SITE WAS RADIAL. ANOTHER VOYAGER DILATATION CATHETER WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0082662

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR