BEUDAMED
    FDA Adverse Event Death Summary report: N

    A4F03, 3F-80CM, (PREM) SYNTEL CATHETER

    MDR report key: 11713137 · Received April 23, 2021

    Report

    Report Number
    2027111-2021-00458
    Event Type
    Death
    Date Received
    April 23, 2021
    Date of Event
    April 9, 2021
    Report Date
    September 30, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    PMA / PMN Number
    K901627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE BALLOON HAD RUPTURED AND THE SPRING TIP HAD SEPARATED. BASED ON THE EVALUATION OF THE RETURNED UNIT, IT IS LIKELY THAT THE MAXIMUM PULL FORCE FOR THE EVENT UNIT WAS EXCEEDED, WHICH CAUSED THE BALLOON TO RUPTURE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE SPRING TIP SEPARATION AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE SPRING TIP SEPARATION BASED ON THE EVALUATION OF THE RETURNED UNIT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THE HOSPITAL DETERMINED THAT THE CATHETER DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: EMERGENCY EMBOLECTOMY FEMORAL. EVENT OCCURRED AT (B)(6) HOSPITAL. FED IN CATHETER WHEN SHE PULLED OUT CATHETER TIP WAS LEFT BEHIND INSIDE THE PATIENT. CATHETER WAS INTRODUCED AND WHEN SHE PULLED IT OUT THE TIP WAS LEFT BEHIND INSIDE THE PATIENT. ONLY ONE OF MENTIONED CATHETERS INVOLVED IN THE INCIDENT. UNFORTUNATELY THEY OPENED A SECOND TO TRY AND RETRIEVE THE TIP OF THE FIRST ONE AND THE PACKAGING GOT MIXED UP, SO THEY ARE UNSURE WHICH LOT NUMBER WAS THE FAULTY PRODUCT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17MAY2021 FROM [DISTRIBUTOR]. ONLY THE COMPLAINT CATHETER WAS RETURNED FOR INVESTIGATION. THE FACILITY WAS NOT ABLE TO DETERMINE THE LOT NUMBER OF THE COMPLAINT DEVICE SINCE THE PACKAGING WAS MIXED UP BETWEEN THE TWO CATHETERS USED. THE FACULTY DID NOT RETURN THE OTHER CATHETER SINCE THERE WAS NO COMPLAINT WITH THAT UNIT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [MEDICAL DEVICE SAFETY OFFICER] 25AUG21: THERE WAS NO DAMAGE TO THE VESSEL. THE CATHETER DID NOT OCCLUDE THE VESSEL. ANOTHER CATHETER WAS USED TO COMPLETE THE CASE. THE SURGEON DID NOT HAVE ANY DIFFICULTY INSERTING THE CATHETER. THE HOSPITAL DETERMINED THAT THE CATHETER DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH AS THE PATIENT HAD ACUTE MYOCARDIAL INFARCTION 6 HOURS POST-OP. FURTHER COMMENT, IT IS NOTED BY THE CONSULTANT RESPONDING THAT THIS HAS HAPPENED PREVIOUSLY. IT¿S USUALLY CAUSED BY THE CATHETER TIP PASSING INTO A SMALL SIDE BRANCH WHERE IT BECOMES STUCK. SOMETIMES IF YOU PULL HARD ENOUGH YOU MAY END UP AVULSING THE SIDE BRANCH BUT IN THIS CASE IT LOOKS AS THOUGH THE TIP SEPARATED WITHOUT ANY ADVERSE EFFECT. PATIENT STATUS: PATIENT DEATH. TYPE OF INTERVENTION: NI.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: EMERGENCY EMBOLECTOMY FEMORAL. FED IN CATHETER WHEN SHE PULLED OUT CATHETER TIP WAS LEFT BEHIND INSIDE THE PATIENT. CATHETER WAS INTRODUCED AND WHEN SHE PULLED IT OUT THE TIP WAS LEFT BEHIND INSIDE THE PATIENT. ONLY ONE OF MENTIONED CATHETERS INVOLVED IN THE INCIDENT. UNFORTUNATELY THEY OPENED A SECOND TO TRY AND RETRIEVE THE TIP OF THE FIRST ONE AND THE PACKAGING GOT MIXED UP, SO THEY ARE UNSURE WHICH LOT NUMBER WAS THE FAULTY PRODUCT. INTERVENTION: NI. PATIENT STATUS: PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614054 A4F03, 3F-80CM, (PREM) SYNTEL CATHETER CATHETER, EMBOLECTOMY DXE APPLIED MEDICAL RESOURCES A4F03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death