BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F (

    MDR report key: 8436454 · Received March 20, 2019

    Report

    Report Number
    3006260740-2019-00603
    Event Type
    Death
    Date Received
    March 20, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    NIE
    PMA / PMN Number
    K133456
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF AN EVENT WHICH RESULTED IN CATHETER PLACEMENT THROUGH THE LEFT ATRIUM AND LEFT VENTRICLE WAS INCONCLUSIVE DUE TO LACK OF SUBSTANTIATING INFORMATION. THE COMPLAINANT INDICATED THAT A TRIALYSIS CATHETER PLACEMENT WAS ATTEMPTED THROUGH THE RIGHT I.J., USING AN ¿ARROW¿ GUIDEWIRE, WHICH RESULTED IN PLACEMENT THROUGH THE LEFT ATRIUM AND LEFT VENTRICLE. NORMAL CATHETER PLACEMENT RESULTS IN THE CATHETER TIP BEING PLACED IN THE LOWER SUPERIOR VENA CAVA. CAUTIONS AND WARNINGS ARE PRESENT IN THE PRODUCT IFU TO ADVISE AVOIDING PLACING EITHER THE GUIDEWIRE OR CATHETER IN THE RIGHT ATRIUM. AT NO POINT IS THE LEFT ATRIUM OR VENTRICLE ALONG THE PATHWAY OF NORMAL PLACEMENT AND IT WAS IMMEDIATELY UNKNOWN HOW THEY WERE ALLEGEDLY PUNCTURED. ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES ASSOCIATED WITH THE EVENT WAS NOT RECEIVED. NO PRODUCT WAS RETURNED FOR PHYSICAL EVALUATION. A REVIEW OF THE QUALITY INSPECTION RECORDS ASSOCIATED WITH THE IMPLICATED LOT FOUND NO POTENTIALLY RELATED EVENTS DURING LOT PRODUCTION. THE ¿ARROW¿ WIRE USED WAS STATED TO BE 24CM IN LENGTH WHICH WAS RELATIVELY SHORT FOR THE 15CM INSERTION LENGTH CATHETER ALLEGED TO BE USED IN THE EVENT. THE RELATIVELY SHORT WIRE COULD FEASIBLY PRESENT UNANTICIPATED COMPLICATIONS WITH THE PROCEDURE AND IT WAS ALSO UNKNOWN WHAT ADDITIONAL PRODUCT CHARACTERISTICS THE ¿ARROW¿ GUIDEWIRE MAY HAVE HAD WHICH COULD HAVE POTENTIALLY CONTRIBUTED TOWARDS THE EVENT. BD UTILIZES GUIDEWIRES CONTAINING A ¿J¿ TIP IN THIS PRODUCT TO HELP MITIGATE THE RISK OF VESSEL TRAUMA. NO INFORMATION WAS ULTIMATELY PROVIDED WHICH SUGGESTED A BD PRODUCT DEFICIENCY MAY HAVE CONTRIBUTED TO THE EVENT AND THE DETAILS SURROUNDING HOW THE ALLEGED PATIENT INJURY OCCURRED WERE UNKNOWN. THE PRODUCT IFU CONTAINS THE FOLLOWING INFORMATION POTENTIALLY RELEVANT TO THE EVENT, ¿CANNULATION OF THE LEFT INTERNAL JUGULAR VEIN WAS REPORTEDLY ASSOCIATED WITH A HIGHER INCIDENCE OF COMPLICATIONS COMPARED TO CATHETER PLACEMENT IN THE RIGHT JUGULAR A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TRIALYSIS WAS PLACED IN LEFT IJ PLACEMENT WITH US RESULTED IN PLACEMENT THROUGH LEFT ATRIUM AND THROUGH LEFT VENTRICLE. PHYSICIAN UTILIZED ARROW 24 CM GUIDEWIRE. CATHETER WAS REMOVED IN OR. PATIENT PLACED ON BYPASS. LEFT VENTRICLE REPAIRED. PATIENT TAKEN OFF BYPASS AND WENT INTO PEA. NO RHYTHM AFTER 30 MINUTES DESPITE CARDIAC MASSAGE. NO OTHER INFORMATION PROVIDED. (B)(6) 2019 - PHYSICIAN STATED HE BELIEVED CLINICIAN UTILIZED ARROW GUIDEWIRE BECAUSE ARROW WAS STIFFER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TRIALYSIS WAS PLACED IN LEFT IJ PLACEMENT WITH US RESULTED IN PLACEMENT THROUGH LEFT ATRIUM AND THROUGH LEFT VENTRICLE. PHYSICIAN UTILIZED ARROW 24 CM GUIDEWIRE. CATHETER WAS REMOVED IN OR. PATIENT PLACED ON BYPASS. LEFT VENTRICLE REPAIRED. PATIENT TAKEN OFF BYPASS AND WENT INTO PEA. NO RHYTHM AFTER 30 MINUTES DESPITE CARDIAC MASSAGE. NO OTHER INFORMATION PROVIDED. ON (B)(6) 2019 - PHYSICIAN STATED HE BELIEVED CLINICIAN UTILIZED ARROW GUIDEWIRE BECAUSE ARROW WAS STIFFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230852 POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F ( CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED NIE BARD ACCESS SYSTEMS N/A RECX0498

    Patients

    Seq Age Sex Outcome Treatment
    1 Death