BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1896128 · Received November 10, 2010

    Report

    Report Number
    3005099803-2010-04698
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED TWO KINKS IN THE CATHETER OF THE DEVICE. IN ADDITION, THE BLACK EXIT MARKER WAS FOUND TO BE BUNCHED. FUNCTIONAL TESTING WAS ATTEMPTED; HOWEVER, THE DEVICE COULD NOT PASS THROUGH THE 2.8MM ENDOSCOPE DUE TO KINKS IN THE CATHETER. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE COMPLAINT THAT THE BLACK EXIT MARKER WAS "CRINKLED" WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED LIMIT THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF EXIT MARKER BUNCHED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND PYLORIC DILATATION PROCEDURE PERFORMED ON A (B)(6) FEMALE PATIENT ON (B)(6) 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN ATTEMPTING TO ADVANCE THE CATHETER DOWN THE WORKING CHANNEL OF THE ENDOSCOPE (OLYMPUS, UNKNOWN MODEL). THE BALLOON WAS REMOVED FROM THE ENDOSCOPE, AND IT WAS FOUND THAT THE BLACK EXIT MARKER WAS "CRINKLED". THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND PYLORIC DILATATION PROCEDURE PERFORMED ON A (B)(6) FEMALE PATIENT ON (B)(6) 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN ATTEMPTING TO ADVANCE THE CATHETER DOWN THE WORKING CHANNEL OF THE ENDOSCOPE ((B)(4), UNKNOWN MODEL). THE BALLOON WAS REMOVED FROM THE ENDOSCOPE, AND IT WAS FOUND THAT THE BLACK EXIT MARKER WAS "CRINKLED". THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    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 M00558500 13288757

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR STANDARD (B)(4) EGD ENDOSCOPE (MODEL UNK)