BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1860762 · Received October 7, 2010

    Report

    Report Number
    3005099803-2010-04215
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE MODEL, CATALOG NUMBER OR LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. (B)(4) - BLEEDING; NON-SURGICAL INTERVENTION REQUIRED. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04248 ADDRESSES THE POLYFLEX STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFLEX ESOPHAGEAL STENT SYSTEM AND CRE BALLOON DILATATION CATHETER WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON A (B)(6) FEMALE PATIENT ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD SUFFERED A RADIATION-INDUCED STRICTURE OF THE ESOPHAGUS (DETAILS OF THE RADIATION PROCEDURE ARE UNKNOWN). DURING THE TREATMENT PROCEDURE, THE PHYSICIAN ATTEMPTED TO PRE-DILATE THE SEVERE STRICTURE TO 13MM USING A CRE BALLOON IN ORDER TO ACCOMMODATE THE POLYFLEX DELIVERY SYSTEM. WHILE DILATING, THE STRICTURE SITE BEGAN TO BLEED. THERE WAS NO ALLEGED MALFUNCTION OF THE CRE BALLOON DILATATION CATHETER. THE PHYSICIAN USED HEMOSTASIS CLIPS (UNKNOWN NUMBER, REPORTED TO BE A "COUPLE") TO STOP THE BLEED. DURING THE PROCEDURE, DIFFICULTY WAS ALSO EXPERIENCED WHILE PREPPING THE POLYFLEX STENT FOR DEPLOYMENT. THE PHYSICIAN COULD NOT LOAD THE STENT ONTO THE DELIVERY SYSTEM - THE PROXIMAL FLAIR OF THE STENT INFOLDED DURING MULTIPLE LOADING ATTEMPTS. THE POLYFLEX STENT WAS NEVER USED IN THE PATIENT AND THE PHYSICIAN ABORTED THE PROCEDURE. THE PHYSICIAN IS PLANNING TO PLACE A STENT AT A LATER DATE, HOWEVER, NO FURTHER INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK UNK99

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention