BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUTONIX 018 DRUG COATED BALLOON PTA CATHETER

    MDR report key: 8615315 · Received May 16, 2019

    Report

    Report Number
    3006513822-2019-00078
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 16, 2019
    Manufacturer
    C.R. BARD, INC. (GFO)
    Product Code
    ONU
    UDI-DI
    00801741177705
    PMA / PMN Number
    P130024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS/DEVICE EVALUATION: UPON RECEIPT OF THE SAMPLE, VISUAL EXAMINATION WAS PERFORMED OVER THE ENTIRE LENGTH OF THE CATHETER REVEALING DAMAGE TO THE STRAIN RELIEF. UNDER MAGNIFICATION (10-30X) IT WAS OBSERVED, THE AREA APPROXIMATELY 135 MM FROM THE MOST DISTAL MARKER BAND HAS STRIATIONS ON BOTH SIDES OF THE BALLOON WHILE UNDER NEGATIVE PRESSURE. THE BALLOON MATERIAL DID NOT APPEAR TO BE TWISTED AS ALLEGED BY THE HCP. FUNCTIONAL TESTING DETERMINED THE BALLOON WAS ABLE TO BE INFLATED AND DEFLATED. THE ENTIRE BALLOON WAS INFLATED TO 8 ATMS WHILE MAINTAINING A UNIFORM SHAPE WITHOUT A DROP IN PRESSURE. A LOT HISTORY REVIEW REVEALED THIS IS THE ONLY COMPLAINT REPORTED FOR LOT GFCY0418 FOR THE ALLEGATION OF A TWISTED BALLOON. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. CONCLUSION: RETURNED SAMPLE ANALYSIS DID NOT REVEAL TWISTING IN THE BALLOON MATERIAL WHILE IT WAS INFLATED TO NOMINAL PRESSURE. THE DHR REVIEW CONCLUDED THE BALLOON WAS MANUFACTURED TO SPECIFICATION UPON RELEASE OF THE SAMPLE. HOWEVER, A REVIEW OF THE RECEIVED FLUOROSCOPIC IMAGE PROVIDED BY THE HCP, ALLEGEDLY REPRESENTS A NON UNIFORM, TWISTED, PARTIALLY INFLATED LUTONIX DCB IN THE IMAGE. BASED ON THE INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. IT IS UNKNOWN IF THE PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES KNOWN TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE PROVIDED WILL ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS DIFFICULT TO INFLATE WITH TWO PORTIONS OF THE BALLOON NOT FULLY INFLATING. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS. REPORTEDLY, THE TARGET LESION WAS NOT PRE-DILATED, BUT ATHERECTOMY WAS PERFORMED WITH A CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK. THE LUTONIX DCB WAS DELIVERED TO THE TARGET LESION OVER AN 014 VIPER GUIDEWIRE THROUGH A 45 CM 6 FRENCH TERUMO INTRODUCER SHEATH. REPORTEDLY, THE LUTONIX DCB WAS INFLATED WITH A BOSTON SCIENTIFIC INFLATION DEVICE. HOWEVER, THE INFLATION PRESSURE IS UNKNOWN. THE PHYSICIAN OBSERVED, UNDER FLUOROSCOPY, THE BALLOON MATERIAL TWISTING ON THE PROXIMAL AND DISTAL ENDS. THE LUTONIX DCB WAS DEFLATED AND REMOVED FROM THE PATIENT WITHOUT ISSUES. THE SAMPLE WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411490 LUTONIX 018 DRUG COATED BALLOON PTA CATHETER DRUG COATED BALLOON PTA CATHETER ONU C.R. BARD, INC. (GFO) 9014 GFCY0418 00801741177705

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR