BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIBA BIOPSY NEEDLE

    MDR report key: 9926094 · Received April 4, 2020

    Report

    Report Number
    1820334-2020-00746
    Event Type
    Injury
    Date Received
    April 4, 2020
    Date of Event
    November 30, 2018
    Report Date
    June 19, 2020
    Manufacturer
    COOK INC
    Product Code
    MJG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: BASED ON REVIEW OF SALES HISTORY ON 10JUN2020 FOR NEFF PERCUTANEOUS ACCESS SETS, IT IS LIKELY THAT THE CHIBA NEEDLE REFERENCED BY THIS REPORT WAS A COMPONENT OF A NEFF PERCUTANEOUS ACCESS SET RATHER THAN AN INDEPENDENT DEVICE SOLD SEPARATELY. THIS REPORT WAS SENT TO ADDRESS THE CHIBA NEEDLE. BECAUSE IT IS NOW BELIEVED THAT THIS NEEDLE IS A COMPONENT OF THE SET ADDRESSED BY MEDWATCH REPORT#: 1820334-2020-00745, THIS REPORT WILL BE CANCELLED. INVESTIGATION OF THE CHIBA NEEDLE AS WELL AS ANY ADDITIONAL INFORMATION REGARDING THIS EVENT WILL BE SUBMITTED UNDER MEDWATCH REPORT#: 1820334-2020-00745. NO FOLLOW UP INFORMATION WILL BE SUBMITTED FOR THIS REPORT.

    Description of Event or Problem · 0

    CORRECTION REGARDING PATIENT IDENTIFIERS OF RELATED REPORTS: MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE NEFF PERCUTANEOUS ACCESS SET. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE 22-G CHIBA NEEDLE (THIS REPORT).

    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: 22-G CHIBA NEEDLE. PRODUCT CODE: MJG. CONCOMITANT MEDICAL PRODUCTS: SELF-EXPANDING METALLIC STENTS, NEFF PERCUTANEOUS SET (COOK), 0.035 IN GUIDEWIRE, 5F HEADHUNTER OR COBRA CATHETER, 6F SHEATH, STIFF 260CM X 0.035 INCH GUIDEWIRE, GELFOAM PLATELETS. OCCUPATION: UNKNOWN. PMA/510(K) #: EXEMPT. (B)(4). 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 A 22-G CHIBA NEEDLE WAS TAKEN FROM THE FOLLOWING ARTICLE: ZHOU ET AL., "STUDY OF PERCUTANEOUS STENT PLACEMENT WITH IODINE-125 SEED STRAND FOR MALIGNANT BILIARY OBSTRUCTION.¿ CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY 42 (2018): 268-475. THE FOLLOWING IS STATED IN THE ARTICLE: "THIS STUDY INCLUDED 132 PATIENTS WITH MOJ (MALIGNANT OBSTRUCTIVE JAUNDICE) TREATED FROM NOVEMBER 2015 TO OCTOBER 2017. FORTY-FIVE PATIENTS UNDERWENT INSERTION OF SEMS WITH IODINE-125 SEED STRANDS (SEEDS GROUP); THE REMAINING 87 PATIENTS UNDERWENT SEMS PLACEMENT ALONE (CONTROL GROUP). TECHNICAL SUCCESS WAS DEFINED AS ACCURATE, SUCCESSFUL DEPLOYMENT OF SEMS WITH OR WITHOUT IODINE-125 SEED STRAND; CLINICAL SUCCESS WAS DEFINED AS 20% REDUCTION IN SERUM BILIRUBIN WITHIN 1 WEEK AFTER THE PROCEDURE, COMPARED WITH BASELINE. COMPLICATIONS, DURATION OF PRIMARY STENT PATENCY, AND OVERALL SURVIVAL WERE EVALUATED." ¿PROCEDURES WERE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. THE ACCESS SITE WAS CHOSEN ON THE BASIS OF PRE-PROCEDURAL IMAGES. THE INTRAHEPATIC BILE DUCT WAS PUNCTURED WITH A 22-G CHIBA NEEDLE, FOLLOWED BY INSERTION OF A NEFF PERCUTANEOUS ACCESS SET. THE OUTER CANNULA OF THE NEFF SET WAS KEPT, AND CHOLANGIOGRAPHY WAS PERFORMED TO EVALUATE THE OBSTRUCTION SITE. A 0.035-INCH GUIDEWIRE WAS THEN ADVANCED, AND THE OUTER CANNULA OF THE NEFF SET WAS EXCHANGED WITH A 5-F HEADHUNTER OR COBRA CATHETER TO CROSS THE OBSTRUCTION SITE. AFTER MEASUREMENT OF THE LENGTH OF THE STRICTURE, A LONG 5-F SHEATH WAS ADVANCED OVER THE GUIDEWIRE TO THE DUODENUM; THE GUIDEWIRE WAS KEPT WITHIN THE SHEATH. A STIFF GUIDEWIRE 260 CM LONG AND 0.035 INCHES IN DIAMETER WAS INSERTED THROUGH THE SHEATH TO THE DISTAL DUODENUM." "AFTER THE STRICTURE WAS CROSSED, A 6-F SHEATH WAS INTRODUCED OVER THE 0.035-INCH GUIDEWIRE. THEN, AN UNCOVERED SEM WAS INSERTED THROUGH THE SHEATH AND DELIVERED ACROSS THE STRICTURE. CHOLANGIOGRAPHY WAS PERFORMED TO VERIFY STENT PATENCY. THE PUNCTURE APPROACH WAS OCCLUDED WITH GELFOAM PLEDGETS.¿ "TECHNICAL SUCCESS WAS ACHIEVED IN ALL PATIENTS IN BOTH GROUPS." "ALL PATIENTS WERE REGULARLY FOLLOWED UP THROUGH FEBRUARY 2018 OR UNTIL PATIENT DEATH. THE FOLLOW-UP VISITS INCLUDED OUTPATIENT AND TELEPHONE INTERVIEWS. TELEPHONE INTERVIEWS WERE PERFORMED AT 2 WEEKS AND THEN EVERY 3 MONTHS AFTER STENT PLACEMENT. OUTPATIENT INTERVIEWS WERE PERFORMED 1 MONTH AFTER STENT IMPLANTATION. IF OBSTRUCTIVE JAUNDICE RECURRED (CONFIRMED ELEVATION OF BILIRUBIN LEVEL AND DILATATION OF BILE DUCTS ON CT), THE PATIENT WAS ENCOURAGED TO UNDERGO STENT REVISION OR EXTERNAL DRAINAGE." ¿MAJOR COMPLICATIONS OCCURRED IN ONLY ONE PATIENT, IN THE CONTROL GROUP. THE PATIENT DEVELOPED SEVERE HEMOBILIA WITH GASTROINTESTINAL BLEEDING AND UNDERWENT SUPERSELECTIVE HEPATIC ARTERY EMBOLIZATION 1 DAY LATER TO TREAT A PSEUDOANEURYSM CAUSED BY THE PUNCTURE.¿ MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE NEFF PERCUTANEOUS ACCESS SET. MEDWATCH REPORT IDENTIFIED BY PATIENT IDENTIFIER (B)(6) CAPTURES THE 22-G CHIBA NEEDLE (THIS REPORT). PER THE ARTICLE, NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389654 CHIBA BIOPSY NEEDLE MJG COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention