BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPO GUIDE CATHETER

    MDR report key: 1940720 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05879
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: ONLY A 7.9CM SECTION OF THE COMPLAINT DEVICE, INCLUDING THE DISTAL TIP, WAS RETURNED FOR ANALYSIS ALONG WITH AN UNIDENTIFIED .035" GUIDE WIRE. THE SHAFT SECTION AND A 2.5CM LENGTH OF THE POLYURETHANE INNER LAYER OF THE CATHETER WERE LOADED OVER THE GUIDE WIRE, AS RECEIVED. MICROSCOPIC INSPECTION REVEALED SMALL BUBBLES/VOIDS IN THE EXPOSED INNER LAYER OF THE SHAFT. THESE MICRO-VOIDS MAY BE INDICATIVE OF A HEAT PROFILE EXCURSION DURING MANUFACTURING. NO OTHER DAMAGE OR IRREGULARITIES WERE EVIDENT. THE GUIDE WIRE WAS VISUALLY INSPECTED, INCLUDING MICROSCOPIC EXAMINATION OF THE FULL LENGTH OF THE WIRE. NO DAMAGE OR IRREGULARITIES WERE OBSERVED. A SHIP HISTORY WAS PERFORMED AND IDENTIFIED TWO POTENTIAL LOTS SHIPPED TO THIS FACILITY. THE SHOP FLOOR PAPER WORK FOR THESE LOTS WERE REVIEWED FOR THE RELATED ISSUE. THE MOST PROBABLE ROOT CAUSE IS SUPPLIER MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    NO FOREIGN MATERIAL WAS OBSERVED ON THE RETURNED DEVICE. THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO THE SEPARATING OR DELAMINATING OF THE POLYURETHANE INNER LAYER FROM THE OUTER PEBAX LAYER RESULTING IN A SMALLER LUMEN INNER DIAMETER. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A DELAY IN THE COOLING TIME OF CATHETERS THAT WERE LEFT INSIDE CURVING OVENS FOR LONGER PERIODS OF TIME WHEN HEATER ELEMENTS FAILED AND WERE BEING REPLACED. A CORRECTIVE ACTION WAS IMPLEMENTED IN (B)(6) 2010 REQUIRING ALL CATHETERS INSIDE THE OVEN, RAMP, AND SOAK ZONES TO BE SCRAPPED WHENEVER A HEATER ELEMENT FAILS. A TREND ANALYSIS COVERING A 15-MONTH PERIOD ((B)(6) 2011) WAS PERFORMED FOR EXPO' ANGIOGRAPHIC CATHETER WIRE LUMEN BLOCKED/RESTRICTION/DIFFICULTY TRACKING OVER WIRE ISSUES. THE ANALYSIS DISPLAYED A TOTAL OF 23 COMPLAINTS RELATED TO THIS ISSUE. THIS EQUATES TO A FREQUENCY RATE OF FIVE COMPLAINTS PER MILLION UNITS SOLD. ADDITIONALLY, NO PATIENT COMPLICATIONS OR INJURIES HAVE BEEN ASSOCIATED WITH THESE REPORTED EVENTS. THIS INFORMATION IS CONSISTENT WITH THE DOCUMENTED FREQUENCY AND SEVERITY OUTLINED WITHIN THE DEVICE'S RISK DOCUMENTATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A DIAGNOSTIC PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE PHYSICIAN WAS UNABLE TO ADVANCE A .035 GUIDE WIRE THROUGH THE LUMEN OF THIS 5F EXPO DIAGNOSTIC CATHETER DURING PREP. THE CATHETER WAS CUT OPEN AT WHICH POINT A PIECE OF CONSTRAINED PLASTIC WAS NOTED TO BE STUCK IN THE INNER LUMEN OF THE CATHETER. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPO DIAGNOSTIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A DIAGNOSTIC PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE PHYSICIAN WAS UNABLE TO ADVANCE A .035 GUIDE WIRE THROUGH THE LUMEN OF THIS 5F EXPO DIAGNOSTIC CATHETER DURING PREP. THE CATHETER WAS CUT OPEN AT WHICH POINT A PIECE OF CONSTRAINED PLASTIC WAS NOTED TO BE STUCK IN THE INNER LUMEN OF THE CATHETER. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPO DIAGNOSTIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A DIAGNOSTIC PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE PHYSICIAN WAS UNABLE TO ADVANCE A .035 GUIDE WIRE THROUGH THE LUMEN OF THIS 5F EXPO DIAGNOSTIC CATHETER DURING PREP. THE CATHETER WAS CUT OPEN AT WHICH POINT A PIECE OF CONSTRAINED PLASTIC WAS NOTED TO BE STUCK IN THE INNER LUMEN OF THE CATHETER. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPO DIAGNOSTIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPO GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H74908526961

    Patients

    Seq Age Sex Outcome Treatment
    1