BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2243445 · Received September 12, 2011

    Report

    Report Number
    3005099803-2011-03147
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON 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

    THE PROTECTIVE SLEEVE WAS RETURNED FOR EVALUATION; THE CRE BALLOON WAS NOT RETURNED. VISUAL EVALUATION REVEALED THE PROTECTIVE SLEEVE TO BE KINKED. THE CONDITION OF THE RETURNED COMPONENT IS CONSISTENT WITH THE REPORT THAT THE PROTECTIVE SLEEVE WAS STUCK INSIDE THE WORKING CHANNEL OF THE SCOPE. IT SHOULD BE NOTED THAT THE DIRECTIONS FOR USE (DFU) FOR THIS DEVICE INDICATE THE PROTECTIVE SLEEVE TO BE REMOVED PRIOR TO USE. IN THIS CASE, THE PROTECTIVE SLEEVE WAS NOT REMOVED BEFORE USE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. 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 C.R.E. WIREGUIDED BALLOON DILATATION CATHETER DEVICE WAS USED TO TREAT A POST SURGICAL STRICTURE IN THE COLON DURING A COLONOSCOPY ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT A PEDIATRIC OLYMPUS COLONOSCOPE WITH A 3.2MM WORKING CHANNEL WAS USED WITH THE CRE BALLOON. THE COMPLAINANT CONFIRMED THE BALLOON PROTECTOR WAS INADVERTENTLY NOT REMOVED FROM THE C.R.E. BALLOON AND WAS INSERTED INTO THE SCOPE BY THE PHYSICIAN. THE BALLOON PROTECTOR SUBSEQUENTLY BECAME LODGED INTO THE WORKING CHANNEL OF THE SCOPE AND AS A RESULT, THE PHYSICIAN HAD TO REMOVE BOTH THE DEVICE AND SCOPE FROM THE PATIENT. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE CRE BALLOON FOR ITS INTENDED USE. OUTSIDE THE PATIENT, AN ATTEMPT WAS MADE TO RETRIEVE THE BALLOON PROTECTOR FROM THE WORKING CHANNEL OF THE SCOPE; HOWEVER, IT WAS UNSUCCESSFUL. THE SCOPE WAS SENT FOR REPAIR THOUGH THE BALLOON PROTECTOR WAS NOT FOUND WITHIN THE SCOPE AND THE SCOPE WAS SENT BACK INTO SERVICE. THIS SCOPE HAD SINCE BEEN USED , THOUGH NOT WITH ANOTHER CRE BALLOON, AND REPROCESSED WITH NO REPORTED ISSUES. APPROXIMATELY ONE MONTH POST PROCEDURE ON (B)(6) 2011, THE BALLOON PROTECTOR APPEARED OUT OF THE TIP OF THE SCOPE DURING A PROCEDURE. IT WAS CONFIRMED THE BALLOON PROTECTOR DID NOT FALL INTO THE PATIENT. BOTH THE SCOPE AND THE BALLOON PROTECTOR WERE REMOVED WITHOUT COMPLICATIONS. ONCE IT WAS OUTSIDE THE PATIENT, THE BALLOON PROTECTOR WAS PULLED OUT OF THE SCOPE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A C.R.E. WIREGUIDED BALLOON DILATATION CATHETER DEVICE WAS USED TO TREAT A POST SURGICAL STRICTURE IN THE COLON DURING A COLONOSCOPY ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT A PEDIATRIC OLYMPUS COLONOSCOPE WITH A 3.2MM WORKING CHANNEL WAS USED WITH THE CRE BALLOON. THE COMPLAINANT CONFIRMED THE BALLOON PROTECTOR WAS INADVERTENTLY NOT REMOVED FROM THE C.R.E. BALLOON AND WAS INSERTED INTO THE SCOPE BY THE PHYSICIAN. THE BALLOON PROTECTOR SUBSEQUENTLY BECAME LODGED INTO THE WORKING CHANNEL OF THE SCOPE AND AS A RESULT, THE PHYSICIAN HAD TO REMOVE BOTH THE DEVICE AND SCOPE FROM THE PATIENT. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE CRE BALLOON FOR ITS INTENDED USE. OUTSIDE THE PATIENT, AN ATTEMPT WAS MADE TO RETRIEVE THE BALLOON PROTECTOR FROM THE WORKING CHANNEL OF THE SCOPE; HOWEVER, IT WAS UNSUCCESSFUL. THE SCOPE WAS SENT FOR REPAIR THOUGH THE BALLOON PROTECTOR WAS NOT FOUND WITHIN THE SCOPE AND THE SCOPE WAS SENT BACK INTO SERVICE. THIS SCOPE HAD SINCE BEEN USED , THOUGH NOT WITH ANOTHER CRE BALLOON, AND REPROCESSED WITH NO REPORTED ISSUES. APPROXIMATELY ONE MONTH POST PROCEDURE ON (B)(6) 2011, THE BALLOON PROTECTOR APPEARED OUT OF THE TIP OF THE SCOPE DURING A PROCEDURE. IT WAS CONFIRMED THE BALLOON PROTECTOR DID NOT FALL INTO THE PATIENT. BOTH THE SCOPE AND THE BALLOON PROTECTOR WERE REMOVED WITHOUT COMPLICATIONS. ONCE IT WAS OUTSIDE THE PATIENT, THE BALLOON PROTECTOR WAS PULLED OUT OF THE SCOPE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE¿ WIREGUIDED ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558480 0013991633

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR PAEDIATRIC COLONOSCOPE 3.2MM CHANNEL