BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 11283554 · Received February 4, 2021

    Report

    Report Number
    1820334-2021-00257
    Event Type
    Death
    Date Received
    February 4, 2021
    Date of Event
    February 21, 2018
    Report Date
    January 27, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. COOK WAS INFORMED OF A LITERATURE ARTICLE TITLED: BILIARY DRAINAGE IN PATIENTS WITH FAILED ERCP: PERCUTANEOUS VERSUS EUS-GUIDED DRAINAGE (SURG LAPAROSC ENDOSC PERCUTAN TECH, VOLUME 28, NUMBER 3, PAGES 183-187) WHERE THE DATE ACCEPTED FOR PUBLICATION WAS (B)(6) 2018. ALL PATIENTS IN THE ARTICLE WERE SEEN BETWEEN (B)(6) 2009 TO (B)(6) 2016 AT THE NATIONAL INSTITUTE OF MEDICAL SCIENCES AND NUTRITION (B)(6)IN (B)(6), MEXICO. A TOTAL OF (B)(4) PATIENTS WITH (B)(4) PROCEDURES UNDERWENT PERCUTANEOUS BILIARY DRAINAGE. DURING THE PROCEDURES, THE PATIENTS WERE UNDER CONSCIOUS SEDATION WITH SONOGRAPHIC AND FLUOROSCOPIC GUIDANCE. USING A 22-G CHIBA NEEDLE, THE DILATED RIGHT HEPATIC BILIARY TREE WAS ACCESSED. INITIALLY, A NITINOL 0.018-INCH WIRE GUIDE WAS USED, BUT WAS REPLACED BY A COOK 0.035-INCH GUIDEWIRE ROADRUNNER PC WIRE GUIDES WITH AQ HYDROPHILIC COATING [RPN: UNKNOWN]. OVER THE WIRE GUIDE, A COOK BILIARY DRAINAGE CATHETER [RPN: ULT8.5-38-40-P-32S-CLB-RH] WAS ADVANCED AND DEPLOYED IN THE STANDARD MANNER. TWO PATIENTS HAD INTESTINAL PERFORATION WITH SURGICAL MANAGEMENT THAT RESULTED IN TWO PATIENT DEATHS. THIS INVESTIGATION CAPTURES ONE PATIENT INVOLVING THE 0.035-INCH GUIDEWIRE ROADRUNNER PC WIRE GUIDES WITH AQ HYDROPHILIC COATING [RPN: UNKNOWN]. THE LOT NUMBER IS UNKNOWN. A REVIEW OF DOCUMENTATION INCLUDING THE DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL INSPECTIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. DUE TO THIS, NO DIMENSIONAL, VISUAL, OR FUNCTIONAL VERIFICATIONS COULD BE COMPLETED. BASED ON THE KNOWN INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED WITHIN THE CORRECT SPECIFICATIONS AND TOLERANCES. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE'S DESIGN HISTORY FILES (DHF) WERE REVIEWED, AND THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. ALL MATERIALS HAVE BEEN SHOWN TO BE BIOCOMPATIBLE ACCORDING TO ISO 10993-1. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: DEVICE DESCRIPTION: -¿THE ROADRUNNER PC WIRE GUIDE IS COATED WITH AQ (A BIOCOMPATIBLE HYDROPHILIC COATING), WHICH WHEN ACTIVATED BECOMES LUBRICIOUS. THE WIRE GUIDE IS MADE OF NITINOL CORE WITH A DISTAL PLATINUM INNER SPRING COIL TIP, WHICH IS COMPLETELY COVERED BY A BISMUTH-IMPREGNATED POLYMER JACKET.¿ INTENDED USE: -¿THE ROADRUNNER PC WIRE GUIDE IS USED FOR CATHETER POSITIONING AND EXCHANGE IN DIAGNOSTIC AND INTERVENTIONAL PROCEDURES, EXCLUSIVE OF THE CORONARY ARTERIES.¿ WARNINGS: -¿THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION.¿ -¿EXCESSIVE TIGHTENING OF A TORQUE DEVICE MAY ABRADE THE COATING ON THE WIRE GUIDE.¿ PRECAUTIONS: -¿USE MEDICAL IMAGING WHEN MANIPULATING THE WIRE GUIDE. DO NOT ADVANCE OR TORQUE THE WIRE GUIDE WITHOUT VISUAL EVIDENCE OF THE CORRESPONDING MOVEMENT OF THE DISTAL TIP.¿ HOW SUPPLIED: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. IN THE ARTICLE, THE PATIENTS WERE SEEN BETWEEN (B)(6) 2009 TO (B)(6) 2016 AT THE NATIONAL INSTITUTE OF MEDICAL SCIENCES AND NUTRITION (B)(6) IN (B)(6), MEXICO. THEREFORE, A GLOBAL SALES SHIPMENT REPORT WAS CONDUCTED FROM (B)(6) 2006 THROUGH (B)(6) 2016. COOK WAS UNABLE TO NARROW DOWN THE LOT NUMBER OR RPN THIS COMPLAINT PERTAINS TO. THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. FINDINGS OF THIS INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. IT WAS REPORTED THAT THE PATIENT PRESENTED INTESTINAL PERFORATION WITH SURGICAL MANAGEMENT AND SUBSEQUENT DEATH AFTER THE PTBD PROCEDURE WAS PERFORMED. GASTROINTESTINAL PERFORATION IS ALSO KNOWN AS A RUPTURED BOWEL. THIS HAPPENS WHEN A HOLE IN THE WALL OF PART OF THE GASTROINTESTINAL TRACT OCCUR. GASTROINTESTINAL PERFORATION IS AN INHERENT RISK WITH THE PTBD PROCEDURE ESPECIALLY WITH THE USE OF A WIRE GUIDE. NO INFORMATION REGARDING THE PATIENT¿S ANATOMY WAS PROVIDED. IT IS POSSIBLE THAT DUE TO PATIENT ANATOMY OR INADVERTENT USER ERROR THE DEVICE AND/OR CONCOMITANT PRODUCTS WERE MANIPULATED IN A WAY THAT CAUSED A GASTROINTESTINAL PERFORATION TO OCCUR.. BASED ON THE LIMITED INFORMATION INCLUDED IN THE ARTICLE AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THIS WAS AN ADVERSE EVENT RELATED TO THE PATIENT¿S CONDITION AND/OR THE PROCEDURE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EVENT OCCURRED SOMETIME (B)(6) 2009 TO (B)(6) 2016. SUSPECT MEDICAL DEVICE: DEVICE DESCRIBED AS 0.035-INCH GUIDEWIRE ROADRUNNER PC WIRE GUIDES WITH AQ HYDROPHILIC COATING. COMMON DEVICE NAME: UNKNOWN AS EXACT DEVICE IDENTITY IS NOT KNOW PMA/510(K) #: UNKNOWN AS EXACT DEVICE IDENTITY IS NOT KNOW (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE BELOW DESCRIPTION OF AN ADVERSE EVENT WAS TAKEN FROM THE FOLLOWING ARTICLE: TELLEZ-AVILA ET AL., ¿BILIARY DRAINAGE IN PATIENTS WITH FAILED ERCP: PERCUTANEOUS VERSUS EUS-GUIDED DRAINAGE.¿ SURGICAL LAPAROSCOPY ENDOSCOPY & PERCUTANEOUS TECHNIQUES VOL. 28.3 (JUNE 2018): 183-187. THE ARTICLE MENTIONS COOK 8.5FR BILIARY DRAINAGE CATHETER AND COOK 0.035-IN ROADRUNNER PC WIRE GUIDES WITH AQ HYDROPHILIC COATING WERE USED FOR PERCUTANEOUS BILIARY PUNCTURE DRAINAGE PROCEDURES. IT IS UNKNOWN WHICH DEVICE WAS INVOLVED IN THIS INCIDENT. THE FOLLOWING IS STATED IN THE ARTICLE: "A TOTAL OF 90 PATIENTS WERE INITIALLY EVALUATED AND 28 WERE EXCLUDED (FIG. 3). THERE WERE 39 (62.9%) WOMEN AND 23 (37.1%) MEN, WITH A MEDIAN AGE OF 55.6 YEARS (RANGE, 22 TO 88 Y)." "PATIENTS WERE SEEN FROM JUNE 2009 TO JUNE 2016 AT THE NATIONAL INSTITUTE OF MEDICAL SCIENCES AND NUTRITION SALVADOR ZUBIRÁN AT MEXICO CITY, MEXICO" "PATIENTS WITH DIAGNOSIS OF BILIARY TRACT OBSTRUCTION WITH AT LEAST 1 FAILED ERCP PROCEDURE OR INACCESSIBLE SECOND DUODENAL PORTION WAS PERFORMED." "ETIOLOGY OF BILIARY OBSTRUCTION WAS MALIGNANCY IN 35 (56.4%) PATIENTS AND BENIGN OBSTRUCTION IN 27 PATIENTS (43.6%)." "TECHNICAL SUCCESS WAS DEFINED AS APPROPRIATE PLACEMENT OF 1 STENT (PLASTIC OR METALLIC) OR BILIARY CATHETER DRAINAGE INTO THE BILE TRACT BY PTBD OR EGBD. CLINICAL SUCCESS WAS DEFINED AS RESOLUTION OF SYMPTOMS THAT CAUSED THE INDICATION OF DRAINAGE OF BILIARY TRACT OR A DECREASE IN BILIRUBIN BY 50% OR MORE IN A LAPSE OF 30 DAYS." "WE CONSIDERED COMPLICATIONS AS FOLLOWS: PERFORATION WAS DIAGNOSED WHEN PNEUMOPERITONEUM WAS EVIDENT ON IMAGING STUDIES ASSOCIATED WITH PERITONEAL SIGNS. BLEEDING WAS DEFINED AS ANY HEMORRHAGIC EVENT THAT REQUIRED ENDOTHERAPY, BLOOD PRODUCT TRANSFUSION, OR INPATIENT OBSERVATION. INFECTION WAS CONSIDERED IF ANY SEPTIC EVENT OCCURRED AFTER THE INITIAL DRAINAGE (PTBD OR EUS GUIDED) AND WAS PROVEN BY NEW-ONSET FEVER, POSITIVE BLOOD CULTURES, OR POSITIVE FLUID CULTURES. STENT MIGRATION WAS DEFINED AS THE NEED TO RETRIEVE A STENT FROM WITHIN THE BILIARY TRACT OR THE ENTERAL LUMEN." "A TOTAL OF 32 PATIENTS WITH 36 PROCEDURES UNDERWENT PERCUTANEOUS BILIARY DRAINAGE." "UNDER CONSCIOUS SEDATION AND WITH SONOGRAPHIC AND FLUOROSCOPIC GUIDANCE, THE DILATED RIGHT HEPATIC BILIARY TREE IS ACCESSED USING A 22-G CHIBA NEEDLE (UNKNOWN MANUFACTURER). INITIALLY, A NITINOL 0.018-INCH GUIDEWIRE (UNKNOWN MANUFACTURER) WAS PASSED BUT WAS SUBSEQUENTLY REPLACED BY A 0.035-INCH GUIDEWIRE (ROADRUNNER PC WIRE GUIDES WITH AQ HYDROPHILIC COATING; COOK INCORPORATED, BLOOMINGTON, IN). OVER THE GUIDEWIRE, A BILIARY DRAINAGE CATHETER (ULT8.5-38-40-P-32S-CLB-RH; COOK INCORPORATED) IS ADVANCED AND DEPLOYED IN THE STANDARD MANNER." "TECHNICAL SUCCESS WAS ACHIEVED IN 25/32 (78.1%), AND CLINICAL SUCCESS WAS ACHIEVED IN 20/25 (80%) PATIENTS." "THE AVERAGE HOSPITAL STAY WAS 12.5 DAYS. COMPLICATIONS WERE OBSERVED IN 6 (18.7%) PATIENTS WHO PRESENTED SEPSIS, WHICH RESPONDED SATISFACTORILY TO ANTIMICROBIAL THERAPY, 2 MORE PATIENTS (6%) PRESENTED INTESTINAL PERFORATION WITH SURGICAL MANAGEMENT AND SUBSEQUENT DEATH OF BOTH PATIENTS. IN THE SAME GROUP OF PTBD, 1 PATIENT HAD AN ANEURYSM OF THE HEPATIC ARTERY REQUIRING ENDOVASCULAR MANAGEMENT BUT LATER DIED OF AN EMBOLISM. MORTALITY WAS 9.4% IN THIS GROUP." MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE 6 PATIENTS IN THE PTBD GROUP THAT EXPERIENCED SEPSIS. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE BILIARY DRAINAGE CATHETER USED IN THE FIRST PATIENT IN THE PTBD GROUP THAT EXPERIENCED INTESTINAL PERFORATION AND SUBSEQUENT DEATH. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE ROADRUNNER WIRE GUIDE USED IN THE FIRST PATIENT IN THE PTBD GROUP THAT EXPERIENCED INTESTINAL PERFORATION AND SUBSEQUENT DEATH. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE BILIARY DRAINAGE CATHETER USED IN THE SECOND PATIENT IN THE PTBD GROUP THAT EXPERIENCED INTESTINAL PERFORATION AND SUBSEQUENT DEATH. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE ROADRUNNER WIRE GUIDE USED IN THE SECOND PATIENT IN THE PTBD GROUP THAT EXPERIENCED INTESTINAL PERFORATION AND SUBSEQUENT DEATH (THIS REPORT). MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE PATIENT IN THE PTBD GROUP THAT EXPERIENCED AN ANEURYSM OF THE HEPATIC ARTERY AND SUBSEQUENT DEATH OF AN EMBOLISM. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177500 UNKNOWN UNKNOWN DQX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death COOK 8.5FR BILIARY DRAINAGE CATHETER.| UNKNOWN MANUFACTURER 22-G CHIBA NEEDLE.| UNKNOWN MANUFACTURER NITINOL 0.018IN GUIDEWIRE.| COOK 8.5FR BILIARY DRAINAGE CATHETER| UNKNOWN MANUFACTURER 22-G CHIBA NEEDLE| UNKNOWN MANUFACTURER NITINOL 0.018IN GUIDEWIRE