BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2040419 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-01006
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A STERLING ES BALLOON CATHETER. THERE WAS DRIED BLOOD IN THE GUIDE WIRE LUMEN. A GUIDE WIRE WAS PROTRUDING 107.0 CM FROM THE HUB, AND 46 CM FROM THE DISTAL TIP. THE GUIDE WIRE COULD NOT BE REMOVED FROM THE CATHETER WITH GENTLE FORCE SO THE DEVICES WERE SOAKED TO LOOSEN AND DISLODGE DRIED BLOOD AND CONTRAST FROM THE DEVICES. THE MAXIMUM OUTER DIAMETER OF THE WIRE (MEASURED WITH A CALIBRATED LASER MICROMETER) WAS .01648¿, WHEREAS THE STERLING ES IS ONLY COMPATIBLE WITH .014¿ GUIDEWIRES. MICROSCOPIC INSPECTION OF THE HUB/MANIFOLD REVEALED THAT THE PROXIMAL END OF THE INNER SHAFT WAS APPROPRIATELY POSITIONED AND ATTACHED. IT WAS ALSO NOTED THAT THE INNER SHAFT AND BALLOON WERE BUNCHED UP/DAMAGED 5 AND 19 MM FROM THE TIP. EXAMINATION OF THE MATERIAL SURROUNDING THE BUNCHED UP INNER DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE DAMAGE. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, CATHETER ENTRAPMENT WITH A GUIDE WIRE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL USING ANOTHER MANUFACTURERS' 5F INTRODUCER. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY (ATA). ANOTHER MANUFACTURERS' GUIDE WIRE CROSSED THE LESION AND THEN A NON-BSC EXTENSION WIRE WAS CONNECTED. THIS 2MM X 20MM X 142CM STERLING ES BALLOON CATHETER WAS ADVANCED OVER THE WIRE TO THE LESION AND INFLATED TWICE TO 6ATMS FOR 120 SECONDS EACH. THE PHYSICIAN WANTED TO EXCHANGE THE BALLOON CATHETER FOR A LARGER BALLOON; HOWEVER, THE STERLING ES BALLOON CATHETER BECAME STUCK WITH THE GUIDE WIRE DURING WITHDRAWAL. THE DEVICES WERE REMOVED FROM THE PATIENT TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134202010 13790847

    Patients

    Seq Age Sex Outcome Treatment
    1 ST. JUDE MEDICAL EXTENSION WIRE| 5F BRITE TIP 23CM INTRODUCER SHEATH| MEDTRONIC INFLATION DEVICE| TREASURE XS12 GUIDE WIRE