BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST-RING TORQUE WIRE GUIDE

    MDR report key: 12541436 · Received September 28, 2021

    Report

    Report Number
    1820334-2021-02233
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    August 19, 2011
    Report Date
    August 25, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. A 2011 JOURNAL ARTICLE ¿TESTICULAR ARTERY EMBOLIZATION FOR THE TREATMENT OF IATROGENIC HEMORRHAGE: REPORT OF TWO CASES¿ BY B.D. NIEDERHAUSER, STATED THAT A 73-YEAR-OLD MAN WITH UNRESECTABLE PANCREATIC ADENOCARCINOMA PRESENTED WITH A DUODENAL PERFORATION AFTER ENDOSCOPIC ULTRASOUND AND BIOPSY. A RESULTING RETROPERITONEAL FLUID COLLECTION WAS CONTROLLED USING A 12.0-F PIGTAIL DRAINAGE CATHETER. AFTER 4 DAYS OF CONTINUED HIGH-OUTPUT DRAINAGE, A SINOGRAM WAS PERFORMED, WHICH SHOWED COMMUNICATION TO THE THIRD PORTION OF THE DUODENUM THROUGH A SIZABLE DEFECT. THE 10-F DRAINAGE CATHETER (MULTIPURPOSE DRAINAGE CATHETER; COOK, INC) WAS REPLACED OVER A STIFF GUIDE WIRE (LUNDERQUIST RING TORQUE WIRE, COOK, INC) AND REPOSITIONED FOR BETTER CONTROL OF THE LEAK. OVER THE NEXT 2 DAYS, THE PATIENT HAD INTERMITTENT BLOODY OUTPUT FROM THE DRAINAGE CATHETER AND NASOGASTRIC TUBE, AND A CT SCAN SHOWED A POSSIBLE VASCULAR PSEUDOANEURYSM IN THE REGION OF THE DRAIN WITH NO SIGNIFICANT RETROPERITONEAL HEMATOMA. ENDOSCOPY WITH CLIPPING OF THE DUODENAL PERFORATION WAS PERFORMED; NO ENDOLUMINAL BLOOD WAS NOTED. A MESENTERIC ANGIOGRAM WAS REQUESTED 4 DAYS AFTER THE FIRST CATHETER EXCHANGE AS BLEEDING WAS SUSPECTED. INJECTION OF CONTRAST AGENT IN THE RIGHT RENAL ARTERY SHOWED THE RIGHT TESTICULAR ARTERY ARISING FROM THE UPPER POLE BRANCH OF THE RIGHT RENAL ARTERY WITH AN AREA OF ACTIVE EXTRAVASATION IMMEDIATELY ADJACENT TO THE DRAINAGE CATHETER. THE TESTICULAR ARTERY WAS SELECTIVELY EMBOLIZED AND NO FURTHER ACTIVE BLEEDING WAS SEEN AFTER EMBOLIZATION. NO OTHER ADVERSE EVENTS WERE REPORTED FOR THIS EVENT. REVIEWS OF DOCUMENTATION INCLUDING THE QUALITY CONTROL, AND INSTRUCTIONS FOR USE (IFU), WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION THE CUSTOMER DID NOT PROVIDE AN RPN OR LOT NUMBER FOR THE COMPLAINT DEVICE. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_FCWG_REV1] ¿FIXED CORE WIRE GUIDES,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿INTENDED USE: FIXED CORE WIRE GUIDES ARE INTENDED TO FACILITATE THE PLACEMENT OF DEVICES DURING DIAGNOSTIC AND INTERVENTIONAL PROCEDURES. PRECAUTIONS: -USE MEDICAL IMAGING WHEN YOU MANIPULATE THE WIRE GUIDE. DO NOT ADVANCE OR MANIPULATE THE WIRE GUIDE WITHOUT VISUAL EVIDENCE OF THE CORRESPONDING MOVEMENT OF THE DISTAL TIP. -WHEN YOU USE THE WIRE GUIDE WITH ANOTHER DEVICE, CONSIDER THE END-HOLE SIZE AND LENGTH OF THE DEVICE IN ORDER TO ENSURE A PROPER FIT BETWEEN THE WIRE GUIDE AND THE DEVICE. HOW SUPPLIED: SUPPLIED STERILIZED BE ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND 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.¿ BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. THERE ARE VERY FEW DETAILS REGARDING THE PLACEMENT AND EXCHANGES OF THE DRAINAGE CATHETERS. IT IS POSSIBLE, THE CUSTOMER/USER HAD DIFFICULTY ADVANCING THE WIRE GUIDE, THOUGH THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    PMA/510(K) #: K171764. 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 REPORT OF A TESTICULAR ARTERY INJURY POSSIBLY DUE TO DRAINAGE CATHETER EXCHANGE WAS TAKEN FROM THE FOLLOWING ARTICLE: NIEDERHAUSER,B. ET. AL., ¿TESTICULAR ARTERY EMBOLIZATION FOR THE TREATMENT OF IATROGENIC HEMORRHAGE: REPORT OF TWO CASES.¿ JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY 22.9 (2011): 1347-1348. THE ARTICLE CONTAINS "TWO CASES OF TESTICULAR ARTERY EMBOLIZATION PERFORMED FOR THE TREATMENT OF IATROGENIC HEMORRHAGE...[ONE] WAS OF UNCERTAIN ETIOLOGY¿RESULTING EITHER FROM AN ENDOSCOPIC DUODENAL PERFORATION OR FROM INJURY DURING A DRAINAGE CATHETER EXCHANGE (CASE REPORT 1)." "A (B)(6) YEAR-OLD MAN WITH UNRESECTABLE PANCREATIC ADENOCARCINOMA PRESENTED TO OUR DEPARTMENT WITH A DUODENAL PERFORATION AFTER ENDOSCOPIC ULTRASOUND AND BIOPSY. A RESULTING RETROPERITONEAL FLUID COLLECTION WAS CONTROLLED USING A 12.0-F PIGTAIL DRAINAGE CATHETER (COOK, INC, BLOOMINGTON, INDIANA) PLACED UNDER COMPUTED TOMOGRAPHY (CT) GUIDANCE FROM A LATERAL APPROACH USING A MODIFIED SELDINGER TECHNIQUE. AFTER 4 DAYS OF CONTINUED HIGH-OUTPUT DRAINAGE, A SINOGRAM WAS PERFORMED, WHICH SHOWED COMMUNICATION TO THE THIRD PORTION OF THE DUODENUM THROUGH A SIZABLE (1 CM) DEFECT. THE 10-F DRAINAGE CATHETER (MULTIPURPOSE DRAINAGE CATHETER; COOK, INC) WAS REPLACED OVER A STIFF GUIDE WIRE (LUNDERQUIST-RING TORQUE WIRE, COOK, INC) AND REPOSITIONED FOR BETTER CONTROL OF THE LEAK. OVER THE NEXT 2 DAYS, THE PATIENT HAD INTERMITTENT BLOODY OUTPUT FROM THE DRAINAGE CATHETER AND NASOGASTRIC TUBE, AND A CT SCAN SHOWED A POSSIBLE VASCULAR PSEUDOANEURYSM IN THE REGION OF THE DRAIN WITH NO SIGNIFICANT RETROPERITONEAL HEMATOMA. ENDOSCOPY WITH CLIPPING OF THE DUODENAL PERFORATION WAS PERFORMED; NO ENDOLUMINAL BLOOD WAS NOTED. A MESENTERIC ANGIOGRAM WAS REQUESTED 4 DAYS AFTER THE FIRST CATHETER EXCHANGE WHEN FRANK BLOOD AND CLOT WERE AGAIN NOTED IN THE NASOGASTRIC TUBE AND DRAINAGE CATHETER, ALONG WITH A 4-DAY HEMOGLOBIN DECLINE OF 4.3 G/DL (12.9 G/DL TO 8.6 G/DL). INJECTION OF CONTRAST AGENT IN THE RIGHT RENAL ARTERY SHOWED THE RIGHT TESTICULAR ARTERY ARISING FROM THE UPPER POLE BRANCH OF THE RIGHT RENAL ARTERY WITH AN AREA OF ACTIVE EXTRAVASATION IMMEDIATELY ADJACENT TO THE DRAINAGE CATHETER (FIG, A). THE TESTICULAR ARTERY WAS SELECTIVELY INJECTED USING A MICROCATHETER. EMBOLIZATION WAS PERFORMED BOTH PROXIMAL AND DISTAL TO THE PSEUDOANEURYSM USING TWO 0.018-INCH, 1.0 CM LONG (HILAL EMBOLIZATION MICROCOIL; COOK, INC) AND TWO 0.018-INCH 3 X 2 MM TORNADO (COOK, INC) COILS; NO FURTHER ACTIVE BLEEDING WAS SEEN AFTER EMBOLIZATION (FIG, B)." NO OTHER ADVERSE EFFECTS WERE REPORTED OR CONTAINED WITHIN THE ARTICLE. THE 12 FR PIGTAIL DRAIN IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6). THE 10 FR MULTIPURPOSE DRAIN IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6). THE LUNDERQUIST-RING TORQUE WIRE IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6) (THIS REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439429 LUNDERQUIST-RING TORQUE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention COOK 10 FR MULTIPURPOSE DRIAN| COOK 12 FR PIGTAIL DRAIN| COOK 10 FR MULTIPURPOSE DRIAN| COOK 12 FR PIGTAIL DRAIN