BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY¿

    MDR report key: 2964240 · Received February 15, 2013

    Report

    Report Number
    2134265-2013-00745
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K953602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE BALLOON WAS FOLDED AND WRAPPED AROUND THE SHAFT OF THE DEVICE. NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. DURING ANALYSIS, A 0.035 INCH GUIDEWIRE WAS INSERTED FROM THE DISTAL HUB AND PUSHED THROUGH THE WIRE LUMEN EXITING OUT THROUGH THE TIP. A SMALL, IRREGULARLY SHAPED PIECE OF TRANSLUCENT MATERIAL THAT WAS PLIABLE TO TOUCH WAS PUSHED OUT WHEN THE GUIDEWIRE EXITED THROUGH THE TIP. THE LUMEN WAS FLUSHED WITHOUT ISSUE AND WATER WAS NOTED TO BE COMING FROM THE DISTAL TIP OF THE DEVICE AS EXPECTED. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE PIECE OF MATERIAL WAS SENT FOR FTIR ANALYSIS AND ALL MATCHES WERE FOR SILICONE BASED MATERIALS WITH THE STRONGEST BEING A 76% MATCH FOR POLYDIMETHYLSILOXANE. THIS COMPOUND CONSTITUTES 1.923% OF THE MEDIGLIDE COATING OF SYMMETRY DEVICES AND DOES NOT POSE A DANGER TO THE PATIENT. MEDIGLIDE IS PULSED THROUGH THE CATHETERS IN A MACHINE FOR 1 SECOND DURING THE MANUFACTURING PROCESS. THIS COMPOUND IS WIDELY FOUND IN MEDICAL IMPLANTS, WATER REPELLENT, LUBRICANT AND IN ANTIALLERGENIC CREAMS AND LOTIONS (ROYAL SOCIETY OF CHEMISTRY, THE DICTIONARY OF SUBSTANCES AND THEIR EFFECTS, SECOND EDITION) AND IT IS HIGHLY UNLIKELY THAT THE DEVICE CAME INTO CONTACT WITH ANY OF THESE IN THE OPERATING ROOM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY FOREIGN MATERIAL WAS NOTED. THE TARGET LESION WAS LOCATED IN THE SHUNT OF THE LEFT FOREARM VEIN. DURING FLUSHING OF A 5.0-4/4T/90 SYMMETRY BALLOON CATHETER FOREIGN MATERIAL WAS NOTED ON THE TIP OF DEVICE. THE DEVICE WAS UNABLE TO PROPERLY FLUSH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY FOREIGN MATERIAL WAS NOTED. THE TARGET LESION WAS LOCATED IN THE SHUNT OF THE LEFT FOREARM VEIN. DURING FLUSHING OF A 5.0-4/4T/90 SYMMETRY BALLOON CATHETER FOREIGN MATERIAL WAS NOTED ON THE TIP OF DEVICE. THE DEVICE WAS UNABLE TO PROPERLY FLUSH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67604 SYMMETRY¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001103320 0015161773

    Patients

    Seq Age Sex Outcome Treatment
    1