BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE MAX 20 BALLOON DILATATION CATHETER

    MDR report key: 2010765 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00691
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K972357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED ONLY THE PROXIMAL SECTION OF THE DEVICE WAS RECEIVED. THE DISTAL SECTION WHICH INCLUDES THE BALLOON AND THE TIP OF THE DEVICE WAS NOT RETURNED. A VISUAL AND TACTILE EXAMINATION REVEALED A BREAK HAD OCCURRED IN THE SHAFT 650MM DISTAL TO THE STRAIN RELIEF, JUST ABOVE THE LAP WELD. THE AREA AT THE BREAK WAS SEVERELY STRETCHED FOR 2MM IN LENGTH. THE SHAFT WAS SLIGHTLY FLATTENED 617MM DISTAL TO THE STRAIN RELIEF. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A RADIOPAQUE (RO) MARKER BAND WAS MISSING. THE TARGET LESION WAS LOCATED IN A DIALYSIS GRAFT IN THE ARM. WHILE POSITIONING THE BLUE MAX BALLOON CATHETER, IT WAS NOTED THAT THERE WAS NO DISTAL RO MARKER BAND PRESENT WHEN THEY ATTEMPTED TO TAKE IMAGES. THE PHYSICIAN INFLATED THE BALLOON ONCE WITH NO ISSUE. THE SECOND TIME THE BALLOON WAS INFLATED, THE CONTRAST FLOWED OUT FROM THE DISTAL END OF THE BALLOON. THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BLUE MAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A RADIOPAQUE (RO) MARKER BAND WAS MISSING. THE TARGET LESION WAS LOCATED IN A DIALYSIS GRAFT IN THE ARM. WHILE POSITIONING THE BLUE MAX BALLOON CATHETER, IT WAS NOTED THAT THERE WAS NO DISTAL RO MARKER BAND PRESENT WHEN THEY ATTEMPTED TO TAKE IMAGES. THE PHYSICIAN INFLATED THE BALLOON ONCE WITH NO ISSUE. THE SECOND TIME THE BALLOON WAS INFLATED, THE CONTRAST FLOWED OUT FROM THE DISTAL END OF THE BALLOON. THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BLUE MAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE MAX 20 BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001125640 13782336

    Patients

    Seq Age Sex Outcome Treatment
    1