BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON

    MDR report key: 2082329 · Received May 9, 2011

    Report

    Report Number
    2134265-2011-01678
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE DEVICE WAS RETURNED WITH THE BALLOON DETACHED FROM THE SHAFT. THE BALLOON WAS STILL INSIDE THE PROTECTOR CAP. THERE WAS NO DAMAGE NOTED TO THE SHAFT. THE PROTECTOR CAP WAS REMOVED FROM THE BALLOON WITHOUT ISSUE. ALL BLADES AND BALLOON MATERIAL WERE FOLDED CORRECTLY AND WITHIN THE CORRECT CHANNELS OF THE PROTECTOR CAP. THE BALLOON COULD NOT BE INFLATED TO DETERMINE THE OUTER DIAMETER DUE TO THE DETACHMENT HOWEVER, NO DAMAGE WAS NOTED TO THE BALLOON OR THE BLADES. THE INNER DIAMETER OF THE BALLOON PROTECTOR WAS WITHIN SPECIFICATION. NO OTHER DAMAGE TO THE DEVICE WAS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON DETACHMENT OCCURRED. DURING REMOVAL OF THE BALLOON PROTECTOR FROM THE 4.0 X 1.5CM X 140CM SPCB FLEXTOME MR CUTTING BALLOON, THE BALLOON DETACHED FROM THE CATHETER. THIS DEVICE WAS NEVER IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH D DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON DETACHMENT OCCURRED. DURING REMOVAL OF THE BALLOON PROTECTOR FROM THE 4.0 X 1.5CM X 140CM SPCB FLEXTOME MR CUTTING BALLOON, THE BALLOON DETACHED FROM THE CATHETER. THIS DEVICE WAS NEVER IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH D DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL PERIPHERAL CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 0013589607

    Patients

    Seq Age Sex Outcome Treatment
    1