BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2110542 · Received June 1, 2011

    Report

    Report Number
    2024168-2011-03814
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND A RUPTURE OR SEPARATION WHILE IN THE PATIENT ANATOMY. THE BALLOON WAS SEPARATED 1 CM DISTAL TO THE PROXIMAL SEAL, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACE WAS JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE INNER MEMBER WAS SEPARATED 2.2 CM DISTAL TO THE PROXIMAL SEAL. THE FRACTURE FACE WAS STRETCHED AND JAGGED. THE SEPARATED PORTION OF THE BALLOON (INCLUDING THE TIP) AND INNER MEMBER WERE NOT RETURNED. THE DISTAL SHAFT WAS NECKED DOWN DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 7 MM. THERE WERE THREE KINKS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. 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. IN THIS CASE, IT WAS REPORTED THE LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE RESISTANCE. AS THE CATHETER WAS EVENTUALLY ABLE TO CROSS THE LESION, THE REPORTED RESISTANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. 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. 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; HOWEVER IT WAS NOTED THAT THE BALLOON WAS INFLATED TO 28 ATM, WHICH IS ABOVE THE RATED BURST PRESSURE (RBP). IT SHOULD BE NOTED THE NC VOYAGER INSTRUCTIONS FOR USE (IFU) STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED RBP. USE OF A PRESSURE-MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. IT IS LIKELY THAT THE OVER PRESSURIZATION OF THE BALLOON RESULTED IN THE BALLOON RUPTURING. ADDITIONALLY, AN INTERACTION OF THE RUPTURED BALLOON AND THE HEAVILY CALCIFIED PATIENT ANATOMY LIKELY RESULTED IN THE RESISTANCE DURING REMOVAL AND ANY FURTHER MANIPULATION IN THE ATTEMPTS TO REMOVE THE CATHETER WOULD HAVE RESULTED IN THE SHAFT STRETCHING AND ULTIMATELY SEPARATING. FURTHER HANDLING DURING PACKING FOR RETURN ANALYSIS LIKELY CONTRIBUTED TO THE NOTED KINKS IN THE HYPOTUBE. IT WAS REPORTED THAT AFTER THE BALLOON SEPARATED, THE LAD HAD COMPLETELY OCCLUDED. DUE TO THE OCCLUSION, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. OCCLUSION AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS LISTED IN THE NC VOYAGER IFU. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO NON-ABBOTT BALLOONS WERE ADVANCED, BUT MET RESISTANCE AND WERE UNABLE TO CROSS. THE VOYAGER NC BALLOON ALSO MET RESISTANCE DURING ADVANCEMENT, BUT WAS ABLE TO REACH THE LESION SITE. THE BALLOON WAS INFLATED 3 TIMES AND DURING THE 3RD INFLATION AT 28 ATMOSPHERES, THE BALLOON RUPTURED. THERE WAS DIFFICULTY RETRACTING THE BALLOON AND IT WAS NOTED THAT THE DISTAL HALF OF THE BALLOON HAD SHEARED OFF AND REMAINED IN THE PATIENT. ANGIOGRAPHY REVEALED THAT THE LAD HAD COMPLETELY OCCLUDED. DUE TO THE OCCLUSION, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. MULTIPLE ATTEMPTS TO RESTORE FLOW TO THE LAD LESION WERE UNSUCCESSFUL AND THE PATIENT WAS SENT FOR EMERGENT CORONARY BYPASS SURGERY. REPORTEDLY, THE PATIENT IS DOING WELL. 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 0121461

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R| S