BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT TUNNELER

    MDR report key: 12186190 · Received July 17, 2021

    Report

    Report Number
    9612007-2021-00029
    Event Type
    Injury
    Date Received
    July 17, 2021
    Date of Event
    May 20, 2021
    Report Date
    August 6, 2021
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K932273
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SHUNT TUNNELER (990010) WAS DISCARDED AT HOSPITAL, THUS NOT AVAILABLE FOR INVESTIGATION. ADDITIONALLY, NO TRACEABILITY INFORMATION WAS PROVIDED; THEREFORE, NO DHR REVIEW COULD BE PERFORMED. THE MALLEABLE TUNNELER MANUFACTURING PROCESS INCLUDES RECEPTION OF THE STAINLESS STEEL TUBE (SHAFT), AND CONTROLS INCLUDE FLEXIBILITY TESTING ON EACH LOT, DIMENSIONAL AND VISUAL CONTROLS. MATERIALS CERTIFICATES ARE CONTROLLED FOR THE STAINLESS STEEL SHAFT AND THE POLYAMIDE THREAD AND MATERIAL. POLYAMIDE LINE AND BULLET SHAPED END DIMENSIONAL AND VISUAL CONTROLS ARE PERFORMED AT THE MOLDING OPERATION, ON A SAMPLING BASIS AND AT THE ASSEMBLY STEP ON 100% OF THE TUNNELERS. DURING ASSEMBLY STEP, VISUAL/FUNCTIONAL CONTROLS ARE PERFORMED, INCLUDING CONTROL OF THE JUNCTION STAINLESS STEEL SHAFT/POLYAMIDE BULLET END. AFTER ASSEMBLY AND CONTROL, THE DEVICES ARE PACKAGED, LABELLED AND STERILIZED. IN THE REPORTED INCIDENT, THE SURGEON COMPLAINED THE DEVICE WAS MORE SOFTER AND FLEXIBLE WITH SHARPER TIP THAN THE ONE HE WAS USED TO. THE MALLEABLE TUNNELER WAS MARKETED IN 1992, BASED ON INPUTS FROM NEUROSURGEONS. THE REQUIRED RIGIDITY/MALLEABILITY OF TUNNELERS DEPENDS ON THE PROCEDURE USED BY THE SURGEON AND DEPENDS ON THE PATIENT¿S CHARACTERISTICS. WITHOUT ACTUAL DEVICE TO ANALYZE, COMPLAINT IS CONSIDERED UNVERIFIABLE. WE DO NOT SUSPECT A DEVICE DEFECT. THE COMPLAINT WAS EVALUATED BY INTEGRA SAFETY BOARD AND A MEDICAL ASSESSMENT PERFORMED. THIS ASSESSMENT CONCLUDED THE EVENT WAS PROCEDURALLY RELATED. RISK FILE WAS REVIEWED AND IS DEEMED APPROPRIATE. NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THEY ACCEPTED THE SHUNT TUNNELER (990010) IN REPLACEMENT OF THEIR ORIGINAL ARTICLE 821516 AND USED IT TO PERFORM VENTRICUL-OPERITONEAL SHUNT PLACEMENT, AND PATIENT INJURY OCCURRED. THE PHYSICIANS STATE THAT THE MATERIAL OF THE DEVICE IS SOFTER THAN THE ORIGINAL ARTICLE 821516, AND THAT DUE TO THE INCREASED FLEXIBILITY, A PRECISE TUNNELING IS HARDLY POSSIBLE. THERE WAS AN IMPALING INJURY TO THE PATIENT'S HEART WITH TEARING OF THE PERICARDIUM AND PERFORATION OF THE MYOCARDIUM. ACCORDING TO THE OPERATING SENIOR PHYSICIAN, THE LENGTH OF THE TUNNELING ROD WAS NOT CONTROLLABLE "AS USUAL" AND THE TIP WAS ALSO SIGNIFICANTLY SHARPER, SO THAT NO RESISTANCE WAS FELT IN THE USUAL WAY. THE PATIENT WAS REVIVED (CPR) FOR 45 MINUTES. THIS WAS FOLLOWED BY A STERNOTOMY BY CARDIAC SURGERY WITH MUSCLE AND PERICARDIAL SUTURES. POSTOPERATIVELY, THE PATIENT HAD TO GO TO INTENSIVE CARE UNIT. FORTUNATELY, THE PATIENT RECOVERED FROM THE OPERATION AND IS NOW WELL AGAIN. THE EVENT LED TO SIGNIFICANT INCREASE OF SURGERY TIME OF MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083085 SHUNT TUNNELER VALVE ACCESSORIES JXG INTEGRA NEUROSCICENCS IMPLANTS SA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR