BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2052191 · Received April 12, 2011

    Report

    Report Number
    3005099803-2011-01122
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS OVER 50 YEARS OLD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE BALLOON WAS ABLE TO BE COMPLETELY DEFLATED, HOWEVER THE DEVICE WOULD NOT FIT THROUGH THE SCOPE. IT WAS REPORTED THAT IT SEEMED LIKE THE BALLOON MATERIAL WHERE THE CATHETER MEETS THE BALLOON AT THE DISTIL TIP WAS HARDENED. THE BALLOON MATERIAL WOULD NOT RE-FOLD. THEY HAD TO REMOVE THE SCOPE WITH THE DEVICE INSIDE AND CUT THE CATHETER TO REMOVE THE DEVICE FORM THE SCOPE. ALTHOUGH THE BALLOON WAS ABLE TO BE COMPLETELY DEFLATED, WHICH IS CONTRARY TO WHAT WAS INITIALLY REPORTED, THIS EVENT WILL REMAIN MDR REPORTABLE AS IT UNKNOWN WHAT IS MEANT BY THE REPORT THAT THE BALLOON MATERIAL AT THE DISTAL TIP WAS HARDENED. FOLLOW UP INFORMATION RECEIVED STATED THE DEVICES THAT ARE THE SUBJECTS OF MANUFACTURER REPORT # 3005099803-2011-01122 AND MANUFACTURER REPORT # 3005099803-2011-01123 WERE USED ON DIFFERENT PATIENTS IN DIFFERENT PROCEDURES AND THEREFORE ARE NOT RELATED AS REPORTED INITIALLY. BASED ON ADDITIONAL INFORMATION, THE REPORTED EVENT OF BALLOON MATERIAL "HARDENED".

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE BALLOON DILATATION CATHETERS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01122 ADDRESSES THE FIRST CRE BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-01123 ADDRESSES THE SECOND CRE BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT TWO CRE BALLOON DILATATION CATHETERS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH BALLOONS WOULD NOT FULLY DEFLATE. THE BALLOONS WERE SUCCESSFULLY REMOVED FROM THE PATIENT ANATOMY, HOWEVER DIFFICULTY WAS EXPERIENCED DURING WITHDRAWAL THROUGH THE SCOPE. EACH DEVICE AND ENDOSCOPE WERE REMOVED FROM THE PATIENT TOGETHER AND THE BALLOON CATHETERS WERE CUT IN ORDER TO REMOVE THE DEVICES FROM THE SCOPE. NO VISIBLE ISSUES WERE NOTED TO EITHER DEVICES. THE PROCEDURE HAD BEEN COMPLETED WITH THE SECOND CRE BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE BALLOON DILATATION CATHETERS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01122 ADDRESSES THE FIRST CRE BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-01123 ADDRESSES THE SECOND CRE BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO CRE BALLOON DILATATION CATHETERS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH BALLOONS WOULD NOT FULLY DEFLATE. THE BALLOONS WERE SUCCESSFULLY REMOVED FROM THE PATIENT ANATOMY, HOWEVER DIFFICULTY WAS EXPERIENCED DURING WITHDRAWAL THROUGH THE SCOPE. EACH DEVICE AND ENDOSCOPE WERE REMOVED FROM THE PATIENT TOGETHER AND THE BALLOON CATHETERS WERE CUT IN ORDER TO REMOVE THE DEVICES FROM THE SCOPE. NO VISIBLE ISSUES WERE NOTED TO EITHER DEVICES. THE PROCEDURE HAD BEEN COMPLETED WITH THE SECOND CRE BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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 BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558380 14096037

    Patients

    Seq Age Sex Outcome Treatment
    1 STANDARD EGD SCOPE (MODEL UNKNOWN)