BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCB NEEDLE, CATHETER

    MDR report key: 8649100 · Received May 29, 2019

    Report

    Report Number
    1820334-2019-01337
    Event Type
    Injury
    Date Received
    May 29, 2019
    Report Date
    August 8, 2019
    Manufacturer
    COOK INC
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. A REVIEW OF THE COMPLAINT HISTORY, DRAWING, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS WAS 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. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, INVESTIGATION HAS CONCLUDED THAT THIS EVENT CANNOT BE TRACED TO THE DEVICE, BUT MAY BE TRACED TO THE PROCEDURE AND/OR PATIENT CONDITION. BLEEDING IS A KNOWN RISK OF ANY SURGICAL PROCEDURE. IT IS POSSIBLE THAT THE USER¿S TECHNIQUE DURING THE PROCEDURE AND/OR PATIENT ANATOMY LED TO THE ARTERIAL LACERATION AND BLEEDING. COOK WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING 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

    SUSPECT MEDICAL DEVICE: PRODUCT LISTED AS A "KELLETT NEEDLE." INITIAL REPORTER ALSO SENT REPORT TO FDA: PREAMENDMENT. PMA/510(K) #: PRODUCT INFORMATION UNKNOWN - [(B)(4)].

    Description of Event or Problem · 1

    THE BELOW DESCRIPTION OF EXCESSIVE BLEEDING FOLLOWING PERCUTANEOUS NEPHROLITHOTOMY WAS DESCRIBED IN THE FOLLOWING ARTICLE: THILAGARAJAH, RANJAN, CLARE M ALLEN, ET AL. "SUBCOSTAL ARTERY LACERATION DURING PERCUTANEOUS NEPHROLITHOTOMY: AN UNUSUAL COMPLICATION." J UROL. 163 (2000): 1513-1514. AS STATED IN THE ARTICLE, "A (B)(6)-YEAR-OLD MAN WITH A HISTORY OF PRIMARY MYELOFIBROSIS UNDERWENT PERCUTANEOUS NEPHROLITHOTOMY FOR REMOVAL OR A 3 CM. LEFT RENAL STONE. PREOPERATIVE BLOOD ANALYSIS WAS NORMAL. ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED TO ASSESS THE DEGREE OF TECHNICAL DIFFICULTY CONSIDERING THE EXISTING SPLENOMEGALY . THE LEFT COLLECTING SYSTEM WAS IDENTIFIED USING RETROGRADE URETEROGRAPHY. AN ULTRASOUND TRANSDUCER HEAD WAS PLACED OVER THE LEFT LOIN AND THE PELVICALICEAL SYSTEM CONTAINING THE STONE WAS EASILY SEEN." "USING A KELLETT NEEDLE (COOK INC) IN COMBINATION WITH AN X-RAY IMAGE INTENSIFIER AND ULTRASOUND, ANTEGRADE PUNCTURE OF THE LOWER POLE CALIX WAS PERFORMED INFERIOR TO THE EDGE OF THE 12TH RIB. IN THE ABSENCE OF HEMORRHAGE GRADED DILATION USING A SELDINGER TECHNIQUE PRODUCED A SUBCOSTAL 30FR TRACK. THE STONE WAS DISINTEGRATED USING A PNEUMATIC PROBE AND EXTRACTED. A 30FR PORGES NEPHROSTOMY TUBE WAS PLACED TO TAMPONADE THE TRACK AND ANCHORED WITH AN INNER POLYTETRAFLUOROETHYLENE COATED CATHETER." THE ARTICLE THEN STATES, "POSTOPERATIVELY, EXCESSIVE BLEEDING FROM AROUND THE NEPHROSTOMY SITE CAUSED A LIFE THREATENING HEMORRHAGE, WHICH REQUIRED RAPID FLUID RESUSCITATION. CT REVEALED A LARGE RETROPERITONEAL HEMATOMA APPARENTLY CAUSED BY AN ACTIVELY BLEEDING LOWER RENAL POLE VESSEL." EMBOLIZATION OF THE LOWER RENAL POLE ARTERY, BLOOD TRANSFUSION, AND FURTHER EMBOLIZATION WERE PERFORMED UNTIL THE BLEEDING STOPPED. THE PATIENT WAS DISCHARGED 12 DAYS POSTOPERATIVELY. NO FURTHER ADVERSE EVENTS WERE REPORTED FOLLOWING THE PATIENT'S DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445622 GCB NEEDLE, CATHETER GCB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R