BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 6567102 · Received May 15, 2017

    Report

    Report Number
    2648988-2017-00015
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    April 25, 2017
    Report Date
    April 25, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K922936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 06/01/2017. METHOD: DEVICE HISTORY REVIEW. TREND ANALYSIS. FAILURE ANALYSIS. DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1161586 WAS REVIEWED: LOT NUMBER: 1161586, CATALOG NUMBER: INS5010, DEVICE IDENTIFIER: (B)(4), PRODUCT IDENTIFIER: (B)(4), MANUFACTURING DATE: MAY 26, 2016, EXPIRATION DATE: JULY 21, 2020. UPON REVIEW OF COMPLAINT SYSTEM FROM MAY 2015 TO MAY 2017, THERE ARE FOUR (4) COMPLAINTS RELATED TO ¿GUIDE-WIRE STRIPPED¿. OUT OF THE FOUR (4) COMPLAINTS, TWO (2) ARE UNCONFIRMED. THE OTHER CONFIRMED ONE, AS PER MANUFACTURER¿S (GUIDEWIRE TECHNOLOGIES) EVALUATION, IT WAS CONCLUDED TO BE MOST LIKELY CUSTOMER RELATED (EXCESSIVE FORCE). THE PERCENTAGE OF DEFECTIVE UNITS REPORTED FOR FG LOT# 1161586 WAS CALCULATED TO BE (B)(4)%. APPROXIMATELY (B)(4) UNITS OF LUMBAR DRAINAGE CATHETER PRODUCT GROUP WERE RELEASED FOR DISTRIBUTION FROM MAY 2015 TO MAY 2017. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS THEN (B)(4) %. ONE SAMPLE WAS RECEIVED FROM THE CUSTOMER; IT CONTAINED A CATHETER AND GUIDE WIRE. PART OF THE GUIDE WIRE WAS STILL INSIDE THE CATHETER. UNRAVELLING OF THE WIRE WAS EVIDENT AT THE END OF THE CATHETER. THE GUIDE WIRE END OUTSIDE OF THE CATHETER WAS IN GOOD CONDITION FOR ABOUT 96 CM AND THE INTERNAL WIRE WAS VISIBLE AT THIS END OF THE WIRE. THE INTERNAL WIRE MEASURED ABOUT 100.5 CM LONG (WHICH IS ABOUT THE LENGTH OF THE GUIDE WIRE). THE WIRE WAS PULLED FROM THE CATHETER. IF CATHETER WAS HELD ABOVE THE WIRE, THE CATHETER WOULD SORT OF CRIMP (PROBABLY BECAUSE IT WAS ALREADY UNWOUND). NONETHELESS, IF IT CAME OUT WITH EASE GRABBING ONTO THE CATHETER UNDERNEATH THE WIRE¿S END. THE WIRE WAS NOT STUCK INSIDE THE CATHETER. THE END OF THE WIRE THAT WAS INSIDE THE CATHETER WAS EXAMINED AND IT SEEMED TO BE IN GOOD CONDITION. THE EXTERNAL WIRE WAS UNWOUND TO SEE IF THE INTERNAL WIRE WAS STILL ATTACHED TO THE TIP OF THE GUIDE WIRE. IT WAS FOUND THAT THE INTERNAL WIRE HAD DISCONNECTED FROM THE END OF THE WIRE. WHICH COULD BE CAUSED BY A DEFECT IN THE SOLDERING OR EXCESSIVE FORCE WAS APPLIED WHEN PULLING OUT THE GUIDE WIRE. CATHETER WAS SEEN IN GOOD CONDITION. THERE IS A ¿CURVY¿ SECTION BETWEEN 20 TO 30 CM (±10 CM) FROM THE CLOSED END OF THE CATHETER; WHICH PROBABLY EVIDENCES CRIMPING OF CATHETER FROM HOLDING THE CATHETER, WHILE PULLING ON THE GUIDE WIRE. CATHETER MEASURES APPROXIMATELY CONCLUSION: THE COMPLAINT WAS CONFIRMED SINCE THE GUIDE WIRE WAS RECEIVED UNRAVELED; NONETHELESS, WHEN THE WIRE LEFT INSIDE THE CATHETER WAS PULLED, IT CAME OFF WITH EASE. THIS INDICATES THAT THE WIRE WAS NOT STUCK OR TRAPPED IN ANY MANNER INSIDE THE CATHETER. THE ROOT CAUSE IS UNDETERMINED SINCE IT COULD BE EITHER A MANUFACTURING DEFECT OR USER RELATED.

    Description of Event or Problem · 1

    INSERTION OF A LUMBAR DRAIN AND THE INTRODUCER WIRE STRIPPED. THERE WAS NO PATIENT INJURY. SURGERY DELAY WAS REPORTED (TIME UNKNOWN). ADDITIONAL INFORMATION HAS BEEN REQUESTED. LINKED TO MFG. REPORT NUMBER: 2648988-2017-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349297 HERMETIC LUMBAR CATHETER, CLOSED TIP N/A JXG INTEGRA NEUROSCIENCES PR 1161586

    Patients

    Seq Age Sex Outcome Treatment
    1