BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMICATH

    MDR report key: 11655726 · Received April 13, 2021

    Report

    Report Number
    2245270-2021-00026
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    April 4, 2021
    Report Date
    May 21, 2021
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS NOT CONFIRMED TO BE CAUSED BY MANUFACTURING. WE RECEIVED TWO PARTS OF THE CATHETER AS A SAMPLE. THE CATHETER TUBE OBVIOUSLY BROKE OFF AT 14 CM. STRONG FIBRIN ADHESIONS WERE VISIBLE ALONG THE PROXIMAL CATHETER FRAGMENT. AT APPROX. 3.8 CM THE CATHETER TUBE WAS FLATTENED - PRESUMABLY IT HAD BEEN GRASPED THERE DURING REMOVAL. THE CATHETER TIP WAS OCCLUDED. MICROSCOPIC EXAMINATION SHOWED A ROUGH FISSURED SURFACE AT THE BREAKAGE AREA, TYPICAL OF A CATHETER TUBE TORN OFF BY EXCESSIVE TENSILE FORCE. THE STRONG FIBRIN FORMATION AFTER ONLY 4 DAYS INDICATES A PATIENT REACTION. THIS CAN OCCUR IN VERY RARE CASES AND CAN HAVE VARIOUS CAUSES: - ALLERGIC PATIENT REACTION TO LATEX IF LATEX GLOVES (INCLUDING UNPOWDERED) ARE WORN DURING INSERTION. - ALLERGIC PATIENT REACTION TO PUR (IN VERY RARE CASES). - POOR/INCONVENIENT CATHETER PLACEMENT SO THAT THE WALL OF THE BLOOD VESSEL IS IRRITATED BY CATHETER MOVEMENT. - PRESENCE OF HOSPITAL BACTERIA (AT THE CATHETER TIP). IN CASE OF RECURRENCE, BEFORE DECONTAMINATION OF THE SAMPLE, THE CATHETER TIP SHOULD BE EXAMINED IN THE LABORATORY. THERE WERE NO ABNORMALITIES WHEN CHECKING THE BATCH DOCUMENTATION. A LEAKAGE AND FLOW TEST IS PERFORMED ON EACH CATHETER. A TENSILE STRENGTH TEST IS CARRIED OUT RANDOMLY AS AN IN-PROCESS TEST. FINALLY, THERE ARE TWO 100% COMPLETENESS VISUAL INSPECTIONS AND A SEAL SEAM INSPECTION. THERE IS AN INCOMING GOODS INSPECTION FOR ALL COMPONENTS. THERE IS ONE MORE COMPLAINT FOR BATCH 090920GN. REGARDING A TORN CATHETER TUBE, THERE ARE 27 FURTHER COMPLAINTS FOR CODE 1261.306 WITHIN THE LAST THREE YEARS, NINE OF THEM REGARDING A SNAPPED CATHETER TUBE DURING CATHETER REMOVAL. (B)(4). NO FURTHER ACTIONS ARE TAKEN BY QM, AS THERE ARE NO INDICATIONS OF A PRODUCT-RELATED DEFECT.

    Description of Event or Problem · 0

    THE PREMICATH 30 CM WAS PLACED IN A CHILD 3.7 KG, BORN (B)(6) 2020 (35 WEEKS GESTATION) DUE TO SEIZURES ON (B)(6) 2021 ON THE BACK OF THE RIGHT HAND WITH A 24 G CANNULA. THE PREMICATH WAS FLUSHED WITH NACL, THE STYLET COULD BE PULLED WITHOUT PROBLEMS AFTER PLACEMENT. ONLY GLUCOSE 5% AND NACL 0.9% WERE ADMINISTERED THROUGH THE PREMICATH UNTIL ITS REMOVAL ON (B)(6) 2021. AS THE CHILD'S GENERAL CONDITION IMPROVED, THE PREMICATH WAS SCHEDULED TO BE WITHDRAWN ON (B)(6) .2021. THE FIXATION WAS REMOVED WITHOUT ANY PROBLEMS, UP TO THE 18 MARK THE PREMICATH COULD BE WITHDRAWN CAREFULLY WITHOUT ANY PROBLEMS. FROM THE 18 MARK ONWARDS, RETRACTION WAS NO LONGER POSSIBLE. EVEN UNDER GENTLE (!) PULLING IT WAS NOT POSSIBLE TO REMOVE THE CATHETER. DUE TO THE PENDULUM MOVEMENT UNDER LIGHT TRACTION A DISINFECTION WITH KODAN OR OCTINIDON (CUSTOMER NOT SURE) WAS CARRIED OUT IN ORDER TO AVOID A RISK OF INFECTION. AFTER RENEWED LIGHT TRACTION, THE PREMICATH SNAPPED CLOSE TO THE SKIN. THE DISTAL END COULD NO LONGER BE SAVED AND HAD TO BE SURGICALLY REMOVED IN A PAEDIATRIC CARDIAC SURGERY UNIT OF ANOTHER HOSPITAL. THE PROXIMAL AND DISTAL PART OF THE CATHETER WERE KEPT."

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL BE RETURNED TO VGGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THE PREMICATH 30 CM WAS PLACED IN A CHILD (B)(6) KG, BORN (B)(6) 2020 (35 WEEKS GESTATION) DUE TO SEIZURES ON (B)(6) 2021 ON THE BACK OF THE RIGHT HAND WITH A 24 G CANNULA. THE PREMICATH WAS FLUSHED WITH NACL, THE STYLET COULD BE PULLED WITHOUT PROBLEMS AFTER PLACEMENT. ONLY GLUCOSE 5% AND NACL 0.9% WERE ADMINISTERED THROUGH THE PREMICATH UNTIL ITS REMOVAL ON (B)(6) 2021. AS THE CHILD'S GENERAL CONDITION IMPROVED, THE PREMICATH WAS SCHEDULED TO BE WITHDRAWN ON (B)(6) 2021. THE FIXATION WAS REMOVED WITHOUT ANY PROBLEMS, UP TO THE 18 MARK THE PREMICATH COULD BE WITHDRAWN CAREFULLY WITHOUT ANY PROBLEMS. FROM THE 18 MARK ONWARDS, RETRACTION WAS NO LONGER POSSIBLE. EVEN UNDER GENTLE (!) PULLING IT WAS NOT POSSIBLE TO REMOVE THE CATHETER. DUE TO THE PENDULUM MOVEMENT UNDER LIGHT TRACTION A DISINFECTION WITH KODAN OR OCTINIDON (CUSTOMER NOT SURE) WAS CARRIED OUT IN ORDER TO AVOID A RISK OF INFECTION. AFTER RENEWED LIGHT TRACTION, THE PREMICATH SNAPPED CLOSE TO THE SKIN. THE DISTAL END COULD NO LONGER BE SAVED AND HAD TO BE SURGICALLY REMOVED IN A PAEDIATRIC CARDIAC SURGERY UNIT OF ANOTHER HOSPITAL. THE PROXIMAL AND DISTAL PART OF THE CATHETER WERE KEPT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553269 PREMICATH LONG-TERM INTRAVASCULAR CATHETER LJS VYGON GMBH 1261.306 090920GN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 WK Required Intervention