BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCB NEEDLE, CATHETER

    MDR report key: 8664162 · Received June 3, 2019

    Report

    Report Number
    1820334-2019-01319
    Event Type
    Injury
    Date Received
    June 3, 2019
    Report Date
    August 1, 2019
    Manufacturer
    COOK INC
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION . A REVIEW OF THE COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL 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. SUFFICIENT CONTROLS ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT 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 THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING 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

    DEVICE NAME: SPECIFIC DEVICE INFORMATION UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNSPECIFIED TELESCOPIC METAL DILATORS. OCCUPATION: UNKNOWN. COMPLAINT REPORTED TO THE FDA: UNKNOWN. PMA/510(K) #: PREAMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE BELOW EVENT DESCRIPTION WAS TAKEN FROM THE FOLLOWING JOURNAL ARTICLE: SHAW, G, M.J. KELLETT, AND S.K.S. CHOONG. "MANAGEMENT OF RENAL-VEIN PERFORATION DURING A CHALLENGING PERCUTANEOUS NEPHROLITHOTOMY." J. ENDOUROL. 19.6 (2005): 722-723. PER THE ARTICLE, THE PATIENT WAS "A (B)(6) YEAR-OLD MAN WITH COMPLEX URINARY ANATOMY AS THE RESULT OF PREVIOUS SURGERY SUSTAINED A RENAL-VEIN INJURY DURING PERCUTANEOUS NEPHROLITHOTOMY FOR A STAGHORN CALCULUS WITH A BLOOD LOSS OF 1.5 L." THIS CASE REPORTS MAIN RENAL-VEIN PERFORATION DURING A CHALLENGING PERCUTANEOUS NEPHROLITHOTOMY (PCNL) AND SUBSEQUENT MEDICAL MANAGEMENT OF THE INJURY. THE PATIENT HAD INITIALLY UNDERGONE SHOCKWAVE LITHOTRIPSY (SWL) FOR STONE REMOVAL BUT WAS UNSUCCESSFUL DUE TO HIS ABNORMAL ANATOMY. THEREFORE, PCNL WAS INDICATED AND PERFORMED WITH THE PATIENT IN THE PRONE POSITION. THE PUNCTURE SITE WAS LOCALIZED RADIOGRAPHICALLY. AS STATED, "THE RIGHT UPPER POLE CALIX WAS PUNCTURED WITH A 19 GAUGE KELLETT NEEDLE (COOK INC), AND GAS WAS SEEN ON WITHDRAWAL OF THE STYLET. THIS TRACT WAS DILATED WITH TELESCOPIC METAL DILATORS TO ACCOMMODATE A 28F AMPLATZ SHEATH. IMMEDIATELY AFTER DILATOR REMOVAL, BRISK VENOUS BLEEDING WAS NOTED. A 14F FOLEY BALLOON CATHETER WAS INFLATED PROMPTLY THROUGH THE SHEATH TO TAMPONADE THE TRACT. AN EXPLORATORY LAPAROTOMY REVEALED THAT THE TRACT HAD TRAVERSED THE RENAL SINUS INTO THE RENAL VEIN DIRECTLY BUT NOT THE IVC. THE FOLEY CATHETER WAS EXCHANGED FOR A 28F NEPHROSTOMY CATHETER, WHICH WAS PLACED AT THE ENTRY OF THE MAIN RENAL VEIN INTO THE IVC. HE SUFFERED A 1.5 L BLOOD LOSS." IT WAS FURTHER STATED, "POSTOPERATIVELY, HE WAS MANAGED ON THE INTENSIVE CARE UNIT WITH INTRAVENOUS ANTIBIOTICS AND BED REST AND WAS HEPARINIZED FOR 4 DAYS TO PREVENT VENOUS THROMBOSIS. VASCULAR FLOW WAS MONITORED WITH REGULAR DOPPLER ULTRASONOGRAPHY. A CT SCAN SHOWED NO SIGNIFICANT HEMATOMA AND CONFIRMED THE CATHETER POSITION. THE CATHETER WAS WITHDRAWN 4 CM INTO THE RENAL SINUS/PARENCHYMA UNDER FLUOROSCOPY. ON DAY 7, A NEPHROSTOGRAM REVEALED THE TRACT HAD SEALED COMPLETELY, AND THE CATHETER WAS REMOVED UNEVENTFULLY. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457072 GCB NEEDLE, CATHETER GCB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R