BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2060233 · Received April 15, 2011

    Report

    Report Number
    3005099803-2011-01393
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4) RELATES (B)(4) FOR THE REPORTED EVENT OF BALLOON DAMAGE UNKNOWN. 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS. VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED NO DAMAGE TO THE BALLOON PORTION OF THE DEVICE. FUNCTIONAL TESTING WAS PREFORMED AND THE BALLOON WAS INFLATED AND A PINHOLE LEAK WAS NOTED. BASED ON THE CONDITION OF THE COMPLAINT DEVICE, THE COMPLAINT OF A HOLE WAS A HOLE WAS CONFIRMED, HOWEVER ANALYSIS ALSO CONFIRMED THE BALLOON DID NOT BURST THEREFORE THIS IS NO LONGER A MDR REPORTABLE EVENT. A REVIEW OF THE COMPLAINTS DATABASE REVEALED NO ADVERSE TREND FOR THIS DEFECT TYPE. BASED ON PRODUCT ANALYSIS, AND REVIEW OF THE EVENT DESCRIPTION THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 21, 2011 THAT A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGEAL DILATION PROCEDURE PREFORMED ON A (B)(6) OLD FEMALE PATIENT ON (B)(6), 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINT, DURING PREPARATION, THE BALLOON WAS ATTEMPTED TO BE INFLATED, HOWEVER A ¿BREACH¿ WAS NOTED ON THE BALLOON WALL AND THE DEVICE COULD NOT BE USED. THE ACCOUNT CONFIRMED A HOLE WAS NOTED IN THE BALLOON MATERIAL; HOWEVER THE EXTENT OF THE DAMAGE TO THE BALLOON HAS NOT BEEN CLARIFIED. IN ADDITION, IT HAS NOT BEEN CONFIRMED IF THE BALLOON BURST OR IF IT WAS EVER ABLE TO BE INFLATED OUTSIDE THE PATENT. THEREFORE THIS HAS BEEN DEEMED AN MDR REPORTABLE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 STABLE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT; HOWEVER NO INFORMATION HAS BEEN RECEIVED. IF ANY FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGEAL DILATION PROCEDURE PREFORMED ON A (B)(6) FEMALE PATIENT ON (B)(6) 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINT, DURING PREPARATION, THE BALLOON WAS ATTEMPTED TO BE INFLATED, HOWEVER A "BREACH" WAS NOTED ON THE BALLOON WALL AND THE DEVICE COULD NOT BE USED. THE ACCOUNT CONFIRMED A HOLE WAS NOTED IN THE BALLOON MATERIAL; HOWEVER THE EXTENT OF THE DAMAGE TO THE BALLOON HAS NOT BEEN CLARIFIED. IN ADDITION, IT HAS NOT BEEN CONFIRMED IF THE BALLOON BURST OR IF IT WAS EVER ABLE TO BE INFLATED OUTSIDE THE PATENT. THEREFORE THIS HAS BEEN DEEMED AN MDR REPORTABLE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 STABLE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT; HOWEVER NO INFORMATION HAS BEEN RECEIVED. IF ANY FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558350

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR