BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

    MDR report key: 1771676 · Received July 27, 2010

    Report

    Report Number
    3005099803-2010-03231
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNQ
    PMA / PMN Number
    K050232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED INSIDE THE UNOPENED PACKAGE. VISUAL EVALUATION FOUND A DARK COLORED FIBER, 3MM IN LENGTH, INSIDE THE PACKAGE. THEREFORE, THE COMPLAINT THAT FOREIGN MATTER WAS NOTICED INSIDE THE PACKAGING WAS CONFIRMED. THE ORIGIN OF THE FOREIGN MATTER CANNOT BE DETERMINED, HOWEVER THERE IS AN INVESTIGATION IN PROGRESS TO DETERMINE THE ROOT CAUSE OF FOREIGN MATTER FOUND IN PACKAGING.

    Additional Manufacturer Narrative · 1

    THE DEVICE NEVER LEFT BSC POSSESSION THEREFORE THERE IS NO DATE OF RETURN. THOUGH THE SUSPECT DEVICE WAS INSPECTED BY A BOSTON SCIENTIFIC EMPLOYEE, THE FORMAL INVESTIGATION AND EVALUATION OF THE DEVICE HAS NOT BEEN PERFORMED. THEREFORE, THE ROOT CAUSE HAS NOT YET BEEN DETERMINED. UPON COMPLETED OF THE FAILURE ANALYSIS FOR THIS COMPLAINT, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(6), 2010 THAT A RIGIFLEX DILATATION BALLOON WAS INSPECTED AT A BOSTON SCIENTIFIC DISTRIBUTION CENTER. ACCORDING TO THE DISTRIBUTION CENTER EMPLOYEE, BASED ON AN UNRELATED DEVICE RETURNED FROM A CUSTOMER (SEE MANUFACTURER'S REPORT NUMBER 3005099803-2010-03134) A BOSTON SCIENTIFIC WAREHOUSE EMPLOYEE INSPECTED THIS RIGIFLEX DILATATION BALLOON PACKAGING. OBSERVATION OF THE PACKAGING BY A WAREHOUSE EMPLOYEE REVEALED A WOOLLIKE FIBER INSIDE THE SEALED PACKAGE. THERE WAS NO VISIBLE DAMAGED NOTED ON THE PACKAGING. THERE IS NO PATIENT OR PROCEDURE INFORMATION AS THIS DEVICE WAS NEVER SHIPPED TO A CUSTOMER AND NEVER LEFT THE BSC POSSESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(6), 2010 THAT A RIGIFLEX DILATATION BALLOON WAS INSPECTED AT A BOSTON SCIENTIFIC DISTRIBUTION CENTER. ACCORDING TO THE DISTRIBUTION CENTER EMPLOYEE, BASED ON AN UNRELATED DEVICE RETURNED FROM A CUSTOMER (SEE MANUFACTURER'S REPORT NUMBER 3005099803-2010-03134) A BOSTON SCIENTIFIC WAREHOUSE EMPLOYEE INSPECTED THIS RIGIFLEX DILATATION BALLOON PACKAGING. OBSERVATION OF THE PACKAGING BY A WAREHOUSE EMPLOYEE REVEALED A WOOLLIKE FIBER INSIDE THE SEALED PACKAGE. THERE WAS NO VISIBLE DAMAGED NOTED ON THE PACKAGING. THERE IS NO PATIENT OR PROCEDURE INFORMATION AS THIS DEVICE WAS NEVER SHIPPED TO A CUSTOMER AND NEVER LEFT THE BSC POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - MARLBOROUGH M00554510 60188

    Patients

    Seq Age Sex Outcome Treatment
    1