BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

    MDR report key: 2033051 · Received March 30, 2011

    Report

    Report Number
    3005099803-2011-00939
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K010610
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED RX BIOPSY CAP FOAM SPONGE INSERT FOUND THAT THE FOAM SPONGE HAD DETACHED FROM THE RX BIOPSY CAP; THE BIOPSY CAP WAS NOT RETURNED. SINCE THE RX BIOPSY CAP WAS NOT RETURNED, IT IS NOT KNOWN IF THE CAP WAS DAMAGED DURING USE. FURTHER EXAMINATION FOUND THAT THE STAR SHAPED SLITS ON THE FOAM SPONGE INSERT WERE NOT PERFORATED CORRECTLY; NOT ALL OF THE SLITS WERE COMPLETELY PERFORATED. THIS COULD POTENTIALLY CAUSE DIFFICULTY INSERTING A DEVICE THROUGH THE RX BIOPSY CAP, AND ALSO COULD RESULT IN THE SPONGE DETACHING FROM THE RX BIOPSY CAP DURING DEVICE INSERTION, DUE TO THE DEVICE CATCHING ON THE SPONGE AND NOT HAVING A CLEAN SLIT PATH TO PENETRATE. THE MOST PROBABLE ROOT CAUSE IS SUPPLIER MANUFACTURING. FURTHER INVESTIGATION OF THIS ISSUE IS ONGOING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING DEVICE WITH BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES WITHIN THE COMMON BILE DUCT ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN EXTRACTOR RX RETRIEVAL BALLOON WAS ADVANCED THROUGH THE BIOPSY CAP OF THE RX LOCKING DEVICE. THE BALLOON WAS ADVANCED OVER THE PRELOADED GUIDEWIRE OF THE SPHINCTEROTOME. THE BALLOON WAS APPROXIMATELY 4-5 INCHES INTO THE WORKING CHANNEL OF THE FUJINON ED450XT5 SCOPE WHEN SIGNIFICANT RESISTANCE WAS MET; THE BALLOON WAS REMOVED FROM THE SCOPE. A SECOND OF THE SAME EXTRACTOR RX RETRIEVAL BALLOON WAS ADVANCED OVER THE PRELOADED GUIDEWIRE OF THE SPHINCTEROTOME AND INTO THE WORKING CHANNEL OF THE SCOPE, WHEN SIGNIFICANT RESISTANCE WAS AGAIN MET; THE BALLOON AND THE SCOPE WERE REMOVED FROM WITHIN THE PATIENT. UPON INSPECTION OF THE SCOPE, IT WAS DISCOVERED THAT THE SPONGE FROM THE BIOPSY CAP DISLODGED FROM THE CAP AND BECAME LODGED WITHIN THE WORKING CHANNEL OF THE SCOPE. A FORCEPS DEVICE WAS USED TO PUSH THE SPONGE THROUGH THE SCOPE AND OUT FROM THE END. THE PATIENT WAS RESCOPED AND RECANNULATED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS USING THE SAME RX LOCKING DEVICE, ALONG WITH A COMPETITOR'S BIOPSY CAP. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING DEVICE WITH BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES WITHIN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN EXTRACTOR RX RETRIEVAL BALLOON WAS ADVANCED THROUGH THE BIOPSY CAP OF THE RX LOCKING DEVICE. THE BALLOON WAS ADVANCED OVER THE PRELOADED GUIDEWIRE OF THE SPHINCTEROTOME. THE BALLOON WAS APPROXIMATELY 4-5 INCHES INTO THE WORKING CHANNEL OF THE FUJINON (B)(4) SCOPE WHEN SIGNIFICANT RESISTANCE WAS MET; THE BALLOON WAS REMOVED FROM THE SCOPE. A SECOND OF THE SAME EXTRACTOR RX RETRIEVAL BALLOON WAS ADVANCED OVER THE PRELOADED GUIDEWIRE OF THE SPHINCTEROTOME AND INTO THE WORKING CHANNEL OF THE SCOPE, WHEN SIGNIFICANT RESISTANCE WAS AGAIN MET; THE BALLOON AND THE SCOPE WERE REMOVED FROM WITHIN THE PATIENT. UPON INSPECTION OF THE SCOPE, IT WAS DISCOVERED THAT THE SPONGE FROM THE BIOPSY CAP DISLODGED FROM THE CAP AND BECAME LODGED WITHIN THE WORKING CHANNEL OF THE SCOPE. A FORCEPS DEVICE WAS USED TO PUSH THE SPONGE THROUGH THE SCOPE AND OUT FROM THE END. THE PATIENT WAS RESCOPED AND RECANNULATED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS USING THE SAME RX LOCKING DEVICE, ALONG WITH A COMPETITOR'S BIOPSY CAP. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00545261 13831132

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR