BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIBA BIOPSY NEEDLE

    MDR report key: 9926099 · Received April 4, 2020

    Report

    Report Number
    1820334-2020-00748
    Event Type
    Injury
    Date Received
    April 4, 2020
    Date of Event
    July 19, 2019
    Report Date
    July 16, 2020
    Manufacturer
    COOK INC
    Product Code
    MJG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D2B. -- PRODUCT CODE: MJG. G5 ¿ PMA/510(K) #: EXEMPT. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT A 21 GAUGE CHIBA NEEDLE WAS USED WHERE THE PATIENT DEVELOPED A HEPATIC ARTERIAL BLEEDING DURING TREATMENT FOR A COMMON BILE DUCT (CBD) OBSTRUCTION. THE HEPATIC ARTERIAL BLEEDING WAS SUCCESSFULLY TREATED BY EMBOLIZATION. THE COMPLAINT ORIGINATED FROM A 2019 LITERATURE ARTICLE; THE ARTICLE STUDY INVOLVED PATIENTS WITH A BILIARY OBSTRUCTION DUE TO UNRESECTABLE PANCREATIC CANCER THAT UNDERWENT PERCUTANEOUS METALLIC BILIARY STENT INSERTION. FURTHER COMMUNICATION WITH THE USER FACILITY CLARIFIED THE EXACT PRODUCT IDENTITY. THERE WERE NO REPORTS OF MALFUNCTIONS AND THE OPERATOR CONFIRMED THE COOK DEVICES DID NOT CONTRIBUTE TO ANY COMPLICATIONS. A REVIEW OF THE COMPLAINT HISTORY AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DATA BASE SEARCH DID NOT FIND ANY OTHER COMPLAINTS WITH THE SAME/SIMILAR FAILURE MODE. THE DEVICE MASTER RECORD REVIEW DETERMINED THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. PROPER INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY NONCONFORMING PRODUCT PRIOR TO LOT RELEASE. A REVIEW OF THE PRODUCT¿S INSTRUCTIONS FOR USE [IFU] COULD NOT BE CONDUCTED BECAUSE NO IFU EXISTS FOR CHIBA NEEDLES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A DATA BASE SEARCH COULD ALSO NOT BE COMPLETED DUE TO LACK OF INFORMATION REPORTED BY THE USER. A SALES SHIPMENT SEARCH WAS COMPLETED BUT A SPECIFIC LOT(S) COULD NOT BE DETERMINED. AS RELATED NON-CONFORMANCES COULD NOT BE DETERMINED, AND IT HAS BEEN DETERMINED THAT ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE USER STATED THERE WERE NO REPORTS OF MALFUNCTIONS WITH THE CHIBA NEEDLE. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT THERE WAS NO PROBLEM/ISSUE WITH THE DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

    ADDITIONAL INFORMATION RECEIVED 25JUN2020 STATED NO MALFUNCTION WAS EXPERIENCED WITH THE NEEDLE AND THE DEVICE DID NOT CONTRIBUTE TO ANY PROCEDURAL COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: 22-G CHIBA NEEDLE. PRODUCT CODE: MJG, DEVICE, PERCUTANEOUS, BIOPSY. CONCOMITANT MEDICAL PRODUCTS: INTRAMUSCULAR LIDOCAINE ((B)(6) PHARMACY, (B)(6)), 6 OR 8 MM BALLOON CATHETER (BOSTON SCIENTIFIC, (B)(6)), UNCOVERED STENTS (SENTINOL, BOSTON SCIENTIFIC; OR ZILVER, COOK), COVERED STENTS (HERCULES, S&G BIOTECH, (B)(6); (B)(6) MEDICAL, (B)(6); OR (B)(6) DOUBLE, (B)(6) MEDICAL), 180CM AMPLATZ EXTRA STIFF WIRE GUIDE(COOK). PMA/510(K) #: EXEMPT. EMBOLIZATION REQUIRED TO TREAT HEPATIC ARTERIAL BLEEDING. 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 A SERIOUS INJURY USING AN 22G CHIBA NEEDLE WAS TAKEN FROM THE FOLLOWING ARTICLE: KIM ET AL., ¿ACUTE PANCREATITIS AFTER PERCUTANEOUS INSERTION OF METALLIC BILIARY STENTS IN PATIENTS WITH UNRESECTABLE PANCREATIC CANCER.¿ CLINICAL RADIOLOGY 75 (2020): 57-63. THE FOLLOWING IS STATED IN THE ARTICLE: "DATA FROM 143 PATIENTS (75 MEN, 68 WOMEN; MEAN AGE, 65.8 YEARS; RANGE, 35-88 YEARS) WITH UNRESECTABLE PANCREATIC CANCER WHO UNDERWENT PERCUTANEOUS METALLIC BILIARY STENT INSERTION BETWEEN MARCH 2007 AND DECEMBER 2017 WERE EVALUATED RETROSPECTIVELY." "PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) AND BILIARY STENT INSERTION WERE PERFORMED USING LOCAL ANAESTHESIA WITH INTRAMUSCULAR LIDOCAINE. ANTIBIOTICS WERE ADMINISTERED INTRAVENOUSLY 2 HOURS PRIOR TO THE PROCEDURE AND 48 HOURS AFTERWARDS. THE INTRAHEPATIC BILE DUCT WAS PUNCTURED WITH A 21 G CHIBA NEEDLE (COOK, BLOOMINGTON, IN, USA) UNDER FLUOROSCOPY WITH OR WITHOUT US. WHEN PATIENTS HAD NO SYMPTOMS OR SIGNS OF CHOLANGITIS, PRIMARY STENTING WAS SUBSEQUENTLY PERFORMED. IN CASES OF CHOLANGITIS, AN 8.5- OR 10-F DRAINAGE CATHETER WAS INITIALLY INSERTED TO RELIEVE SYMPTOMS AND BILIARY STENTING WAS RESCHEDULED ONCE SYMPTOMS HAD RESOLVED. THE LEVEL AND LENGTH OF THE COMMON BILE DUCT (CBD) OBSTRUCTION WAS DETERMINED BY CORRELATING CHOLANGIOGRAPHY IMAGES WITH PREVIOUS CROSS-SECTIONAL IMAGES. THE LENGTH OF THE STENT WAS DETERMINED ON THIS BASIS. THE DECISION TO IMPLEMENT PRE-STENTING BALLOON DILATATION USING A 6 OR 8 MM BALLOON CATHETER [OTHER MANUFACTURER] WAS TAKEN BY THE PHYSICIANS ACCORDING TO THEIR PERSONAL PREFERENCE. THE ENDOPROSTHESIS WAS INTRODUCED OVER A 0.035 INCH, 150 CM LONG HYDROPHILIC GUIDEWIRE [OTHER MANUFACTURER] OR 180 CM LONG EXTRA-STIFF AMPLATZ GUIDEWIRE (COOK) AND THEN DEPLOYED ACROSS THE STRICTURE IN ORDER TO COVER THE BILE DUCT APPROXIMATELY 2 CM DISTAL AND PROXIMAL TO THE OBSTRUCTION TO PREVENT TUMOUR OVERGROWTH. AS ALL LESIONS WERE LOCATED WITHIN 3 CM OF THE DUODENAL PAPILLA, THE DISTAL PORTION OF THE STENT WAS PLACED JUST ABOVE THE PAPILLA OR ACROSS THE PAPILLA TO BRIDGE THE DUODENUM. POST-STENTING BALLOON DILATATION WAS NOT PERFORMED. BOTH UNCOVERED STENTS [STENTS, MANUFACTURERS] AND COVERED STENTS [STENTS, MANUFACTURERS] WERE UTILISED." "AFTER STENT INSERTION, A TEMPORARY DRAINAGE CATHETER WAS INSERTED JUST PROXIMAL TO STENT. PRIOR TO CATHETER REMOVAL, THE TEMPORARY DRAINAGE CATHETER WAS CLAMPED AND LEFT IN PLACE FOR 2-3 DAYS TO EVALUATE STENT PATENCY. THE CATHETER WAS SUBSEQUENTLY REMOVED IF CONTRAST MEDIUM FLOWED FREELY THROUGH THE STENT INTO THE DUODENUM AND IF SERUM BILIRUBIN LEVELS WERE MARKEDLY DECREASED OR NORMALISED." "PROCEDURE-RELATED MAJOR COMPLICATIONS OCCURRED IN FOUR PATIENTS (HEPATIC ARTERIAL BLEEDING IN TWO PATIENTS THAT WAS SUCCESSFULLY TREATED BY EMBOLIZATION AND BILOMA IN TWO PATIENTS THAT WAS SUCCESSFULLY MANAGED BY PERCUTANEOUS CATHETER DRAINAGE)." MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE HEPATIC ARTERIAL BLEEDING ASSOCIATED WITH THE AMPLATZ EXTRA STIFF WIRE GUIDE. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE HEPATIC ARTERIAL BLEEDING ASSOCIATED WITH THE 22G CHIBA NEEDLE (THIS REPORT.) MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE BILOMA ASSOCIATED WITH THE AMPLATZ EXTRA STIFF WIRE GUIDE. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE BILOMA ASSOCIATED WITH THE 22G CHIBA NEEDLE. PER THE ARTICLE, NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389656 CHIBA BIOPSY NEEDLE MJG COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10.