BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER

    MDR report key: 2070508 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01428
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    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 MFR: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE TO THE SHAFT. IT WAS NOTED THAT THE DISTAL BALLOON BOND HAD COMPLETELY DETACHED FROM THE DISTAL TIP. APPROXIMATELY 2MM OF THE DISTAL BALLOON SLEEVE HAD BEEN PUSHED INSIDE THE BODY OF THE BALLOON. MICROSCOPIC EXAMINATION NOTED THE PRESENCE OF ADHESIVE AT THE BOND SITE AND INSUFFICIENT ROUGHENING/GRINDING OF THE DETACHED DISTAL BALLOON SLEEVE. THE PROXIMAL BALLOON SLEEVE WAS REMOVED AND EXAMINED MICROSCOPICALLY, SHOWING EVIDENCE OF SUFFICIENT ROUGHENING/GRINDING. THE SHAFT OF THE DEVICE WAS MICROSCOPICALLY EXAMINED AND THERE WAS EVIDENCE THAT IT HAD BEEN MICROBLASTED. THE MANUFACTURING BATCH RECORD REVIEW DID NOT IDENTIFY ANY ISSUES; HOWEVER, THE MOST PROBABLE ROOT CAUSE OF THIS INVESTIGATION IS MANUFACTURING RELATED. (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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER SHAFT WAS BROKEN. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A NON CALCIFIED AND MODERATELY TORTUOUS ANTEBRACHIUM VEIN. THE SYMMETRY SMALL VESSEL BALLOON CATHETER WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED TO 15ATMS FOR 15 SECONDS, 3 TIMES. A LEAK WAS NOTED AT THE DISTAL END OF THE BALLOON; HOWEVER, IT IS UNKNOWN IF THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND WHILE CHECKING THE DEVICE THE SHAFT BROKE PROXIMAL TO THE BALLOON. NO DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER SHAFT WAS BROKEN. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A NON CALCIFIED AND MODERATELY TORTUOUS ANTEBRACHIUM VEIN. THE SYMMETRY SMALL VESSEL BALLOON CATHETER WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED TO 15ATMS FOR 15 SECONDS, 3 TIMES. A LEAK WAS NOTED AT THE DISTAL END OF THE BALLOON; HOWEVER, IT IS UNKNOWN IF THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND WHILE CHECKING THE DEVICE THE SHAFT BROKE PROXIMAL TO THE BALLOON. NO DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001103860 14032542

    Patients

    Seq Age Sex Outcome Treatment
    1 .016 GT GUIDE WIRE| ZEON 5FR INTRODUCER SHEATH