BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREMICATH

    MDR report key: 12246779 · Received July 29, 2021

    Report

    Report Number
    2245270-2021-00097
    Event Type
    Death
    Date Received
    July 29, 2021
    Date of Event
    June 6, 2021
    Report Date
    December 6, 2021
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K954302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS NOT CONFIRMED. WE DID NOT RECEIVE THE FAILED SAMPLE FOR THIS COMPLAINT BUT WERE ABLE TO OBTAIN ANOTHER CATHETER FROM THE SAME BATCH FROM THE CUSTOMER. ACCORDING TO THE CUSTOMER, DUE TO INSUFFICIENT X-RAY CONTRAST, THE CATHETER WAS MISPLACED (PUSHED TOO FAR FORWARD - THE FOLDED TIP WAS NOT NOTICED/SEEN) AND THUS PERMANENTLY PENETRATED THE PERICARDIUM. THIS ULTIMATELY LED TO A PERICARDIAL EFFUSION WHICH REMAINED UNDETECTED AND THEREFORE RESULTED IN THE PATIENT'S DEATH. THERE ARE TYPICAL COMPLICATIONS OF CATHETER PLACEMENT IN NEONATOLOGY, SUCH AS PLEURAL EFFUSION/PERICARDIAL EFFUSION. THIS ALSO OCCURRED IN THE PATIENT. THERE IS AN SOP FOR THE PLACEMENT OF PICC IN NEONATOLOGY FROM SCOTLAND (INTERNATIONAL STANDARD). AMONG OTHER THINGS, THIS ALSO SPECIFIES HOW A PERICARDIAL EFFUSION IS TO BE TREATED AND THAT IT IS A TYPICAL COMPLICATION WITH SUCH A CVC IN THIS FORM. THESE OCCURRENCES ARE KNOWN IN THE LITERATURE AND ARE THEREFORE ALSO THE INTERNATIONAL GUIDELINE ON HOW TO DEAL WITH THIS COMPLICATION AND ARE NOT NECESSARILY ASSOCIATED WITH THE CATHETER. THE PATIENT WAS AN EXTREMELY PREMATURE INFANT (500 G). THE UNDERLYING PROBLEM OF ITEM 1261.XXX IS THE TINY CATHETER TUBE SIZE OF ONLY 1 FR (0.33 MM/0.013 IN). DESPITE 40% CONTRAST IN THE MATERIAL, THIS TINY CATHETER IS SOMETIMES VERY DIFFICULT TO DETECT. IT REQUIRES A VERY EXPERIENCED DOCTOR AND CAREFUL PLACEMENT. IN THE PATIENT INVOLVED HERE, THE ANATOMICAL CONDITIONS WERE CORRESPONDINGLY MORE DIFFICULT DUE TO THE LOW WEIGHT OF ONLY 500 G. IN ADDITION TO THE SAMPLE OF THE RECLAIMED BATCH THAT WAS SENT BACK, IT WAS POSSIBLE TO RE-ANALYZE RETENTION SAMPLES OF THE INVOLVED TUBE BATCH AND THE GRANULATE USED. THE BASO4 (BARIUM SULPHATE) CONTENT WAS DETERMINED AGAIN BY MEANS OF ANNEALING RESIDUES. THE VALUES WERE BETWEEN 39.03% AND 39.48% BASO4 AND THUS WITHIN THE SPECIFICATION (+/- 10 % IS ACCEPTABLE). A REVIEW OF THE BATCH DOCUMENTATION WAS PERFORMED, AND NO ANOMALIES WERE FOUND. AGAIN, THE BASO4 CONTENT TESTS, THE X-RAY CONTRAST DETERMINED IN THE EXTERNAL LABORATORY AND THE DIMENSION TESTS HAD SHOWN NO ABNORMALITIES. THEREFORE, THE INDIVIDUALLY INVOLVED GRANULATE AND TUBE BATCHES WERE RELEASED. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE STRENGTH TEST IS RANDOMLY CHECKED DURING IN-PROCESS TESTING. ADDITIONALLY, INCOMING GOODS INSPECTION AND TWO 100% COMPLETENESS VISUAL INSPECTIONS, AND A SEAL SEAM INSPECTION ARE CONDUCTED DURING MANUFACTURING. THIS IS THE FIRST COMPLAINT CONCERNING BATCH 280220GL, THE FIRST CONCERNING A CLAIMED BAD X-RAY CONTRAST AND THE FIRST COMPLAINT CONCERNING A PERICARDIAL EFFUSION CONCERNING CODE NO. 1261.153 AT ALL. THE MATERIAL OF THE CATHETER TUBE HAS NOT CHANGED SINCE 1997. HOWEVER, WE ARE AWARE THAT THE SETTING PARAMETERS ON X-RAY MACHINES HAVE CHANGED TO MINIMIZE THE RADIATION EXPOSURE FOR THE PATIENT. AT THE SAME TIME, IMAGE PROCESSING SOFTWARE IS USED TO REPROCESS THESE X-RAY IMAGES FROM THE X-RAY MACHINES. OBVIOUSLY, THE PREMICATH IS NOT RECORDED CORRECTLY AND IS DISPLAYED EVEN WORSE. NO FURTHER MEASURES ARE TAKEN BY QUALITY MANAGEMENT, AS THERE ARE NO INDICATIONS OF A PRODUCT-RELATED ERROR AND DUE TO THE MISSING SAMPLE NO FURTHER INVESTIGATION CAN BE MADE.

    Description of Event or Problem · 0

    MALPOSITION OF THE CATHETER TIP DUE TO PROBLEMS OF CATHETER VISUALIZATION WITH X-RAY, LEADING TO THE PATIENT'S DEATH AFTER ONE DAY.

    Additional Manufacturer Narrative · 1

    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

    MALPOSITION OF THE CATHETER TIP DUE TO PROBLEMS OF CATHETER VISUALIZATION WITH X-RAY, LEADING TO THE PATIENT'S DEATH AFTER ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145585 PREMICATH LONG-TERM INTRAVASCULAR CATHETER, LJS VYGON GMBH 1261.153 280220GL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death