BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3242361 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-07179
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF DISTAL TIP BENT. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THE CATHETER TO BE CUT. THE DISTAL TIP OF THE CATHETER WAS NOT KINKED/BENT; THEREFORE, THIS COMPLAINT IS NO LONGER AN MDR REPORTABLE EVENT. DUE TO THE CONDITION OF THE RETURNED DEVICE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THEREFORE, THE COMPLAINT THAT THE BALLOON WOULD NOT INFLATE COULD NOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE THIS ISSUE OCCURRED DUE TO SOME PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED BALLOON WAS USED DURING A DILATATION PROCEDURE IN THE ESOPHAGUS PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, BEFORE THE PROCEDURE, THE DISTAL TIP OF THE BALLOON WAS NOTED TO BE KINKED. THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED BALLOON WAS USED DURING A DILATATION PROCEDURE IN THE ESOPHAGUS PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, BEFORE THE PROCEDURE, THE DISTAL TIP OF THE BALLOON WAS NOTED TO BE KINKED. THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342524 CRE? WIREGUIDED DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558440 15500855

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR