BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 7852130 · Received September 6, 2018

    Report

    Report Number
    3001845648-2018-00417
    Event Type
    Injury
    Date Received
    September 6, 2018
    Report Date
    September 6, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K142688. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. DEVICE EVALUATION; THE ECHO-HD-19-C DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED DOCUMENT BASED INVESTIGATION WAS CONDUCTED. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE DUE TO DIFFICULTIES EXPERIENCED DURING THE PROCEDURE BECAUSE THE DEVICE MAY HAVE BEEN IN A TORQUED/FLEXED POSITION OR DIFFICULT TARGET SITE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS FOR USE, ADVISES THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS OR BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    LITERATURE COMPLAINT: COMPARISON OF EUS-GUIDED TISSUE ACQUISITION USING TWO DIFFERENT 19-GAUGE CORE BIOPSY NEEDLES: A MULTICENTER, PROSPECTIVE, RANDOMIZED, AND BLINDED STUDY. DEWITT (2015). AS REPORTED TO CUSTOMER RELATIONS: "ALL PATIENTS WERE FOLLOWED FOR A MINIMUM OF 6 MONTHS. THE PREVALENCE OF ADVERSE EVENTS RELATED TO THE FNB NEEDLE MALFUNCTION (1/41; 3%) WAS SIMILAR TO TCB NEEDLE MALFUNCTION (2/37; 5%; P= 0.6;"). IN ONE PATIENT WITH SUSPECTED TYPE 2 AUTOIMMUNE PANCREATITIS UNDERGOING FNB OF THE TAIL OF THE PANCREAS, THE NEEDLE WOULD NOT RETRACT INTO THE SHEATH (LIKELY FROM ELEVATOR DEFLECTION OF THE NEEDLE INTO A FIBROTIC GLAND) AFTER THE FIRST ATTEMPTED BIOPSY . THE ENDOSCOPE AND UNRETRACTED NEEDLE WERE REMOVED TOGETHER FROM THE PANCREAS AND OUT OF THE PATIENT. IMMEDIATE REINSERTION OF THE ECHOENDOSCOPE DEMONSTRATED RETROPERITONEAL HEMORRHAGE IN THE LEFT UPPER QUADRANT WHICH WAS CONFIRMED BY CT SCAN THE SAME DAY. THE PATIENT HAD MILD SHOULDER PAIN AND WAS DISCHARGED LESS 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."

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "ALL PATIENTS WERE FOLLOWED FOR A MINIMUM OF 6 MONTHS. THE PREVALENCE OF ADVERSE EVENTS RELATED TO THE FNB NEEDLE MALFUNCTION (1/41; 3%) WAS SIMILAR TO TCB NEEDLE MALFUNCTION (2/37; 5%; P= 0.6; " TABLE 5). IN ONE PATIENT WITH SUSPECTED TYPE 2 AUTOIMMUNE PANCREATITIS UNDERGOING FNB OF THE TAIL OF THE PANCREAS, THE NEEDLE WOULD NOT RETRACT INTO THE SHEATH (LIKELY FROM ELEVATOR DEFLECTION OF THE NEEDLE INTO A FIBROTIC GLAND) AFTER THE FIRST ATTEMPTED BIOPSY (" FIG.1A¿D). THE ENDOSCOPE AND UN RETRACTED NEEDLE WERE REMOVED TOGETHER FROM THE PANCREAS AND OUT OF THE PATIENT. IMMEDIATE REINSERTION OF THE ECHOENDOSCOPE DEMONSTRATED RETROPERITONEAL HEMORRHAGE IN THE LEFT UPPER QUADRANT WHICH WAS CONFIRMED BY CT SCAN THE SAME DAY (" FIG. 1B ¿ D). THE PATIENT HAD MILD SHOULDER PAIN AND WAS DISCHARGED LESS 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693348 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention