BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST 40 PTA BALLOON DILATATION CATHETER

    MDR report key: 6123536 · Received November 22, 2016

    Report

    Report Number
    2020394-2016-01103
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 1, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    UDI-DI
    00801741060632
    PMA / PMN Number
    K120660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE LOT MET ALL RELEASE CRITERIA. VISUAL/MICROSCOPIC INSPECTION: THE BALLOON SIZE FOR THIS PRODUCT IS PRINTED ON THE BALLOON HUB OF THE CATHETER AND IDENTIFIED THE RETURNED SAMPLE AS A 10 MM X 4 CM BALLOON. THE BALLOON WAS RETURNED PARTIALLY INFLATED. NO ANOMALIES WERE NOTED TO THE DEVICE. FUNCTIONAL/PERFORMANCE EVALUATION: THE PATENCY OF THE GUIDEWIRE LUMEN WAS TESTED USING AN IN-HOUSE 0.035¿ GUIDEWIRE, AND IT PASSED WITHOUT ISSUE. THE BALLOON WAS CONNECTED TO AN IN-HOUSE INFLATION DEVICE, WITHOUT THE ONE WAY VALVE ATTACHED. VACUUM WAS PULLED ON THE DEVICE AND THE BALLOON WAS COMPLETELY DEFLATED. AN ATTEMPT WAS THEN MADE TO INFLATE THE BALLOON. THE BALLOON WAS INFLATED TO RBP (40 ATM), AND THEN DEFLATED. THE BALLOON TOOK THE APPROPRIATE SHAPE UPON INFLATION AND WAS NOT ASYMMETRICAL IN APPEARANCE. THE DEFLATION TIME OF THE BALLOON WAS APPROXIMATELY 4.0 SECONDS, WHICH IS WITHIN THE SPECIFICATION. THE SAME TEST WAS REPEATED WITH THE INFLATION LUER ATTACHED, YIELDING THE SAME RESULTS MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE DEVICE WAS RETURNED. THE INVESTIGATION IS UNCONFIRMED FOR DEFLATION ISSUES, AS THE BALLOON WAS ABLE TO BE INFLATED AND DEFLATED WITHOUT ISSUE DURING LABORATORY TESTING. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. IT SHOULD BE NOTED THAT PER THE REPORTED EVENT DETAILS, IT WAS STATED THAT THE DEVICE WAS INFLATED WITH A SYRINGE. THE IFU (INSTRUCTIONS FOR USE) STATES THAT THE USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. IT IS UNKNOWN WHETHER THE BALLOON/CATHETER WAS OVERPRESSURIZED OR THE USE OF A SYRINGE CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: - DO NOT EXCEED THE RBP RECOMMENDED FOR THIS DEVICE. BALLOON RUPTURE MAY OCCUR IF THE RBP RATING IS EXCEEDED. TO PREVENT OVER PRESSURIZATION, USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED. - WHEN THE CATHETER IS EXPOSED TO THE VASCULAR SYSTEM, IT SHOULD BE MANIPULATED WHILE UNDER HIGH-QUALITY FLUOROSCOPIC OBSERVATION. DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION. PRECAUTIONS: - IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER THROUGH THE INTRODUCER SHEATH, DETERMINE IF CONTRAST IS TRAPPED IN THE BALLOON WITH FLUOROSCOPY. IF CONTRAST IS PRESENT, PUSH THE BALLOON OUT OF THE SHEATH AND THEN COMPLETELY EVACUATE THE CONTRAST BEFORE PROCEEDING TO WITHDRAW THE BALLOON. - IF RESISTANCE IS STILL FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/INTRODUCER SHEATH AS A SINGLE UNIT. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUBCLAVIAN VEIN, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUBCLAVIAN VEIN, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773856 CONQUEST 40 PTA BALLOON DILATATION CATHETER PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. REAS1483 00801741060632

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR