BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CORE BIOPSY NEEDLE

    MDR report key: 11287658 · Received February 5, 2021

    Report

    Report Number
    1820334-2021-00266
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    June 24, 2015
    Report Date
    February 1, 2022
    Manufacturer
    COOK INC
    Product Code
    KNW
    PMA / PMN Number
    K973565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6: ANNEX A, ANNEX E. INVESTIGATION - EVALUATION. DR. (B)(6), FROM (B)(6), INFORMED COOK ON (B)(6) 2021 OF AN INCIDENT INVOLVING A QUICK CORE BIOPSY NEEDLE OF AN UNKNOWN RPN. THE SOURCE OF THIS COMPLAINT IS FROM A MARCH 2015 JOURNAL ARTICLE. THE DISTAL 2 CM OF THE NEEDLE BROKE OFF DURING AN ATTEMPTED BIOPSY OF THE PANCREAS. THE NEEDLE FRAGMENT WAS REMOVED 6 WEEKS LATER DURING A PANCREATODUODENECTOMY TO TREAT THE PANCREATIC MASS. THE EVENT DATE WAS APPROXIMATELY 8 YEARS AGO. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE 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. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. THOUGH A SALES SHIPMENT SEARCH WAS COMPLETED, COOK WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER FOR THE SUBJECT DEVICE. 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_QC_REV6 ¿QUICK-CORE BIOPSY NEEDLES AND SETS,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE ¿2. PRIOR TO INSERTION, PREPARE THE QUICK-CORE BIOPSY NEEDLE BY PULLING BACK ON THE PLUNGER UNTIL A FIRM CLICK IS FELT. THIS INDICATES THAT THE NEEDLE SPRING IS LOCKED INTO READY POSITION. 3. WITH THE STYLET FULLY RETRACTED, SO THAT THE SPECIMEN NOTCH IS COMPLETELY COVERED BY THE CUTTING CANNULA, ADVANCE THE NEEDLE TO THE AREA TO BE BIOPSIED. DO NOT ADVANCE STYLET UNTIL QUICK-CORE BIOPSY NEEDLE IS IN POSITION. 4. WHILE MAINTAINING NEEDLE POSITION, ADVANCE STYLET WITH THUMB, TO EXPOSE SPECIMEN NOTCH WITHIN THE AREA TO BE BIOPSIED. 5. FIRE THE CUTTING CANNULA BY FULLY DEPRESSING THE PLUNGER WITH THUMB TO CAPTURE TISSUE WITHIN THE SPECIMEN NOTCH.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. 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

    DATE OF EVENT: EVENT OCCURRED SOMETIME BETWEEN FEBRUARY 2012 AND SEPTEMBER 2013. 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: DEWITT, JOHN ET. AL., "COMPARISON OF EUS-GUIDED TISSUE ACQUISITION USING TWO DIFFERENT 19-GAUGE CORE BIOPSY NEEDLES: A MULTICENTER, PROSPECTIVE, RANDOMIZED, AND BLINDED STUDY." ENDOSCOPY INTERNATIONAL OPEN 2015; 03(05): E471-E478. THE FOLLOWING IS STATED IN THE ARTICLE: "THE AIMS OF THIS PROSPECTIVE, RANDOMIZED STUDY WERE TO COMPARE THE DIAGNOSTIC ACCURACY (PRIMARY ENDPOINT) AND THE NUMBER OF NEEDLE PASSES, TOTAL SPECIMEN BIOPSY LENGTH, SUCCESS OF IMMUNOHISTOCHEMICAL LABELING AND COMPLICATION RATES (SECONDARY END POINTS) OF THE 19-GAUGE EUS-TCB AND THE 19-GAUGE EUS-FNB NEEDLE IN PATIENTS WITH A LESION FOR WHICH A HISTOLOGIC DIAGNOSIS IS REQUIRED." "INCLUSION CRITERIA WERE PATIENTS OVER 18 YEARS WITH LESIONS OR ORGANS MEASURING AT LEAST 2CM IN MAXIMAL DIAMETER THAT WERE EXPECTED TO REQUIRE A HISTOLOGIC DIAGNOSIS (I.E. MESENCHYMAL TUMORS, GRANULOMATOUS DISEASE, INDETERMINATE HEPATITIS, AUTOIMMUNE PANCREATITIS) OR CONFIRMATORY IMMUNOCHEMISTRY TO ESTABLISH A DIAGNOSIS (I.E. PANCREATIC ENDOCRINE TUMORS). PATIENTS WITH A PREVIOUSLY NONDIAGNOSTIC EUS-FNA WITHIN THE PREVIOUS 60 DAYS WERE ALSO CONSIDERED FOR ENROLLMENT." "CONSENTED PATIENTS WERE CONSECUTIVELY RANDOMIZED TO EITHER EUS-FNB WITH A 19-GAUGE HISTOLOGY NEEDLE (PROCORE, COOK MEDICAL INC., WINSTON-SALEM, NC; UNITED STATES) OR EUS-TCB WITH A 19-GAUGE HISTOLOGY NEEDLE (QUICK-CORE, COOK MEDICAL INC., WINSTON-SALEM, NC; UNITED STATES). PATIENTS AND STUDY PATHOLOGISTS WERE BLINDED TO THE NEEDLE UTILIZED. THE ENDOSCOPIST AND STUDY COORDINATORS WERE NOT BLINDED." "PATIENTS UNDERWENT UP TO THREE BIOPSIES WITH THE INITIAL NEEDLE. THE FIRST BIOPSY WAS PERFORMED AND PLACED EITHER DIRECTLY IN FORMALIN OR ONTO FILTER PAPER TO PERMIT INSPECTION OF SPECIMEN ADEQUACY. BASED ON PREVIOUSLY PUBLISHED WORK, ADEQUATE SPECIMENS IN THE CURRENT STUDY WERE CONSIDERED TO HAVE AT LEAST 15MM OF TISSUE FOR LIVER BIOPSIES AND AT LEAST 3MM OF TISSUE FOR ALL OTHER SITES [13¿15]. IF INSPECTION REVEALED AN INADEQUATE SPECIMEN, UP TO TWO ADDITIONAL PASSES WERE MADE WITH THE INITIAL NEEDLE. IF THREE PASSES DID NOT RETRIEVE AN ADEQUATE SPECIMEN OR IF THERE WAS TECHNICAL FAILURE DURING ANY PART OF THE SAMPLING PROCESS PROHIBITING FURTHER BIOPSIES, PATIENTS WERE CROSSED OVER TO UNDERGO UP TO THREE PASSES WITH THE OTHER NEEDLE. NO TOUCH PREPS OR CRUSH SMEARS WERE PREPARED FROM THE CORE BIOPSIES. RESCUE FNA WITH A 19-, 22-, OR 25-GAUGE NEEDLE AND ON-SITE PATHOLOGY REVIEW WITH CELL BLOCK PREPARATION WAS PERMITTED IF BOTH NEEDLES WERE CONSIDERED TO YIELD VISIBLY INADEQUATE SPECIMENS ON VISUAL INSPECTION AND THE ENDOSCOPIST BELIEVED THAT CYTOLOGY COULD PROVIDE AN ADEQUATE TISSUE DIAGNOSIS." "ALL PROCEDURES WERE PERFORMED BY OR UNDER THE SUPERVISION OF ONE OF FOUR EXPERIENCED ATTENDING ENDOSONOGRAPHERS. EXAMINATION WAS INITIATED IN SELECT PATIENTS WITH AN OLYMPUS GF-UE160 RADIAL ECHOENDOSCOPE (OLYMPUS AMERICA, INC.; CENTER VALLEY, PENNSYLVANIA, UNITED STATES). CURVILINEAR ARRAY ENDOSONOGRAPHY THEN WAS PERFORMED USING THE OLYMPUS GF-UC140P OR GFUC160-AL5 (OLYMPUS AMERICA, INC.) ENDOSCOPE. TO PERFORM EUS-TCB, THE 19-GAUGE BIOPSY DEVICE WAS INITIALLY PLACED IN THE ¿FIRING POSITION,¿ AND THE NEEDLE ASSEMBLY WAS ADVANCED THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE LESION WAS PUNCTURED AND THE TRAY WAS ADVANCED BY DEPRESSING THE PLUNGER ON THE PROXIMAL SIDE OF THE NEEDLE....EUS-TCB CORE BIOPSY SPECIMENS WERE RETRIEVED BY EXPOSURE OF THE TISSUE TRAY." "CORE BIOPSY SPECIMENS WERE IMMEDIATELY PLACED IN FORMALIN AND SUBSEQUENTLY EMBEDDED IN PARAFFIN. TISSUE BLOCKS WERE STAINED BY HEMATOXYLIN END EOSIN (H&E) AND ADDITIONAL IMMUNOHISTOCHEMISTRY WAS PERFORMED AS NEEDED. EACH SPECIMEN WAS EXAMINED BY ONE EXPERIENCED GASTROENTEROLOGY PATHOLOGIST AT EACH HOSPITAL BLINDED TO THE NEEDLE TYPE. SPECIMENS WERE ASSESSED FOR TOTAL SPECIMEN LENGTH AND FOR ADEQUACY TO PROVIDE BOTH A HISTOLOGIC DIAGNOSIS AND DESIRED IMMUNOHISTOCHEMICAL STUDIES. CYTOLOGY SPECIMENS IF REQUIRED WERE INTERPRETED BY A CYTOPATHOLOGIST SEPARATE FROM THE PATHOLOGIST WHO INTERPRETED THE CORE BIOPSY." "TECHNICAL SUCCESS WITH ANY ATTEMPTED BIOPSY WAS DEFINED AS SUCCESSFUL COMPLETION OF ALL STEPS FROM NEEDLE INSERTION INTO THE ENDOSCOPE ACCESSORY CHANNEL TO TISSUE PROCUREMENT. INABILITY TO COMPLETE ANY STEP WITHIN WAS DEFINED AS TECHNICAL FAILURE FOR THAT ATTEMPTED BIOPSY. IN THE ABSENCE OF SURGICAL RESECTION, DIAGNOSTIC HISTOLOGY (WITH IMMUNOHISTOCHEMISTRY IF PERFORMED) PROVIDED BY FNB OR TCB WAS CONSIDERED THE GOLD STANDARD. WHEN DIAGNOSTIC HISTOLOGY OR CYTOLOGY WAS NOT AVAILABLE, A DEFINITIVE DIAGNOSIS WAS ESTABLISHED ON THE BASIS OF LONG-TERM FOLLOW UP, SURGERY, OR FURTHER PROCEDURES OF BIOPSY. A SUSPECTED BENIGN DIAGNOSIS WAS CONFIRMED BY CLINICAL FOLLOW UP (=6 MONTHS)AND OTHER IMAGING TESTS TO ENSURE THAT NO MALIGNANCY DEVELOPED." "BETWEEN FEBRUARY 2012 AND SEPTEMBER 2013, 85 PATIENTS WERE SCREENED AND 85 WERE CONSENTED AND RANDOMIZED TO EUS-FNB (N=44) OR EUS-TCB (N=41). SEVEN PATIENTS WERE EXCLUDED...THE REMAINING 78 WERE BIOPSIED WITH FNB (N=41) OR TCB (N=37)." "TWO PATIENTS WITH TCB HAD ADVERSE EVENTS RELATED TO THE NEEDLE. IN THE FIRST, THE DISTAL 2CMOF THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING PLUNGER DEPRESSION OF THE NEEDLE DURING THE FIRST ATTEMPTED TRANSDUODENAL BIOPSY OF A PANCREATIC HEAD MASS (FIG. 2A¿ E). THE RESIDUAL NEEDLE FRAGMENT WAS NOT VISIBLE WITH WHITE LIGHT ENDOSCOPY BUT WAS CONFIRMED BY REPEAT EUS AND NON-CONTRAST CT. AFTER SURGICAL CONSULTATION, THE PATIENT WAS DISCHARGED TO HOME. SIX WEEKS LATER THE PATIENT UNDERWENT PANCREATODUODENECTOMY FOR TREATMENT OF THE PANCREATIC MASS AND REMOVAL OF THE NEEDLE FRAGMENT. PATHOLOGY FROM SURGICAL RESECTION CONFIRMED CHRONIC PANCREATITIS.THE SECOND PATIENT WITH AN ADVERSE EVENT RELATED TO THE TCB NEEDLE HAD THE SHEATH-NEEDLE ASSEMBLY BREAK OFF AT THE ACCESSORY CHANNEL DURING BIOPSY OF A PANCREATIC HEAD MASS. PATHOLOGY DIAGNOSIS FROM THIS FIRST AND ONLY TCB PASS AS WELL AS BOTH CROSSOVER FNB BIOPSIES DEMONSTRATED PET." THIS ADVERSE EVENT WAS CLASSIFIED AS "MILD IN SEVERITY." COMPLICATIONS WERE MANAGED SUCCESSFULLY AS OUTPATIENTS AND RESOLVED WITHIN 48 HOURS. FURTHER CORRESPONDENCE WITH THE PHYSICIAN STATED THE PATIENT WAS ADMITTED OVERNIGHT AND CT SHOWED A SMALL HEMATOMA AROUND THE STOMACH. THE PATIENT WAS DISCHARGED WITHIN 24 HOURS. THE FIRST PATIENT IS RECORDED UNDER MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6). THE SECOND PATIENT IS RECORDED UNDER MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) (THIS REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182952 QUICK CORE BIOPSY NEEDLE KNW INSTRUMENT, BIOPSY KNW COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown