BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE? FIXED WIRE

    MDR report key: 3822470 · Received May 21, 2014

    Report

    Report Number
    3005099803-2014-01959
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF BALLOON DEFLATION FAILED. 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 OF THE COMPLAINT DEVICE REVEALED THAT ONLY THE SHAFT AND NOT THE BALLOON WAS RETURNED. THE BALLOON CATHETER WAS CUT WITH A WIRE CUTTER IN ORDER TO REMOVE THE DEVICE OUT FROM THE SCOPE. THE CATHETER SHAFT WAS INSPECTED FOR COSMETIC DEFECTS AND 2 KINKS WERE PRESENT AT 97MM AND 112.5MM FROM THE DISTAL TIP. THE CATHETER WAS NOT CONNECTED TO AN INFLATION DEVICE AND THE BALLOON WAS NOT INFLATED AS THERE WAS NO BALLOON ATTACHED. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO REMOVE THE INFLATION MEDIUM BUT THE PHYSICIAN COULD NOT REMOVE ALL THE INFLATION MEDIUM FROM THE BALLOON. THE MOST PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS COMPLAINT AS IT IS MOST LIKELY THAT THE ISSUE OCCURRED DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE. 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 FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE BALLOON HAD A LEAK UPON INFLATION CAUSING IT NOT TO HOLD PRESSURE. DURING DEFLATION, THEY COULD NOT FULLY DEFLATE THE BALLOON. REPORTEDLY, THE BALLOON CATHETER WAS CUT WITH A WIRE CUTTER TO RETRIEVE THE DEVICE OUT FROM THE SCOPE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS PERFORMED ON (B)(4) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE BALLOON HAD A LEAK UPON INFLATION CAUSING IT NOT TO HOLD PRESSURE. DURING DEFLATION, THEY COULD NOT FULLY DEFLATE THE BALLOON. REPORTEDLY, THE BALLOON CATHETER WAS CUT WITH A WIRE CUTTER TO RETRIEVE THE DEVICE OUT FROM THE SCOPE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303849 CRE? FIXED WIRE DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558370 16613138

    Patients

    Seq Age Sex Outcome Treatment
    1