BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 2222115 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02836
    Event Type
    Death
    Date Received
    August 24, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. ADDITIONAL INFORMATION ALTHOUGH THE EXACT DATE OF DEATH IS UNKNOWN, THE PATIENT DEATH OCCURRED BETWEEN (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. THEREFORE, A DEVICE EVALUATION HAS NOT BEEN PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE REVIEW OF THE DEVICE LABELING CONFIRMED THE DEVICE WAS USED ACCORDING TO THE LABELING IN THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF FOUR COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2011-02565, MFR. REPORT # 3005099803-2011-02619, MFR. REPORT # 3005099803-2011-02800, AND 3005099803-2011-02836.) IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA-JAGWIRE GUIDEWIRE, A WALLFLEX ENTERAL DUODENAL STENT, A TANDEM XL ERCP CANNULA, AND A CRE DILATATION BALLOON WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A SEVERE STRICTURE WITHIN THE DUODENUM AS A RESULT OF PANCREATIC CANCER. THE HYDRA-JAGWIRE GUIDEWIRE (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02565) AND THE TANDEM ERCP CANNULA (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02800) WERE INSERTED INTO THE INTESTINAL TRACT. HOWEVER, DURING POSITIONING, THE GUIDEWIRE AND CANNULA PERFORATED THE INTESTINAL WALL OF THE DUODENUM. THE PERFORATION WAS NOT DETECTED AT THIS TIME. A CRE BALLOON DILATATION CATHETER (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02836) WAS USED TO DILATE THE ANATOMY. NO VISIBLE ISSUES WERE NOTED TO THE CANNULA AND BALLOON AND NO FUNCTIONAL ISSUES WERE EXPERIENCED DURING DILATATION OF THE BALLOON. DURING STENT PLACEMENT, THE HYDRA-JAGWIRE GUIDEWIRE WAS ADVANCED THROUGH THE STRICTURE AND POSITIONED AT THE DESIRED SITE. AT THIS TIME, IT WAS NOTED THAT THE GUIDEWIRE HAD BENT INTO A "C" SHAPE. THE WALLFLEX ENTERAL DUODENAL STENT SYSTEM (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02619) WAS ADVANCED OVER THE GUIDEWIRE. HOWEVER, AS THE STENT SYSTEM WAS POSITIONED AT THE STRICTURE, THE HYDROPHILIC COATING OF THE GUIDEWIRE PEELED OFF. THE GUIDEWIRE WAS WITHDRAWN AND INSPECTED. IT WAS REPORTED THAT THE CORE OF THE WIRE APPEARED TO BE INTACT. THE COATING FRAGMENTS WERE LEFT WITHIN THE PATIENT AT THE DISTAL END OF THE STRICTURE. THE PHYSICIAN DID NOT EXPRESS CONCERN OVER LEAVING THE COATING FRAGMENTS WITHIN THE PATIENT AND DETERMINED THAT THE FRAGMENTS WOULD PASS NATURALLY WITHOUT CAUSING HARM TO THE PATIENT. IN THE PHYSICIAN'S ASSESSMENT, THE GUIDEWIRE COATING DETACHED MOST LIKELY DUE TO THE TORTUOUS ANATOMY. THE PHYSICIAN THEN INSERTED THE OTHER END OF THE SAME HYDRA-JAGWIRE GUIDEWIRE INTO THE PATIENT TO COMPLETE THE PROCEDURE. THE WALLFLEX ENTERAL DUODENAL STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DURING THE STENT PLACEMENT PROCEDURE. PRIOR TO THE STENT PLACEMENT, THE PERFORATION WAS DETECTED VIA X-RAY. IN THE PHYSICIAN'S ASSESSMENT, THE PERFORATION WAS CAUSED BY THE GUIDEWIRE AND THE CANNULA. THE BALLOON DILATION EXACERBATED THE PERFORATION. AS THE PERFORATION WAS DETECTED PRIOR TO STENT PLACEMENT, THE STENT DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, THERE WAS NO MALFUNCTION OF THE STENT. THE FOLLOWING DAY, THE PATIENT DEVELOPED PERITONITIS. POOLING OF AIR WAS NOTED IN THE ABDOMINAL CAVITY AND THE PERFORATION WAS CONFIRMED BY X-RAY IMAGE AND CT SCAN. THE PHYSICIAN CONSIDERED AN OPERATION FOR THE PERITONITIS AND CONSULTED WITH THE PATIENT'S FAMILY, BUT CHOSE NOT TO PERFORM THE OPERATION AS THE PATIENT WAS AT AN ADVANCED AGE. SO, THE PHYSICIAN CHOSE CONSERVATIVE MANAGEMENT AND ADMINISTERED ANTIBIOTICS TO TREAT THE PERITONITIS. ON (B)(6) 2011, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT HAD PASSED AWAY. THE DATE OF DEATH IS UNKNOWN, HOWEVER IT WAS REPORTED TO BE BETWEEN (B)(6) 2011. AN AUTOPSY WAS NOT PERFORMED. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS A RESULT OF THE PANCREATIC CANCER AND PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558470 14363811

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death