BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM

    MDR report key: 1530900 · Received November 4, 2009

    Report

    Report Number
    3005188751-2009-00062
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    October 12, 2009
    Report Date
    October 12, 2009
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL CHOSE NOT TO RETRIEVE OR EVALUATE THE DEVICE AS THE PT IS (B) (6) POSITIVE. REVIEW OF THE DEVICE HISTORY CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. WE WERE UNABLE TO DETERMINE HOW THE TIP OF THE SHEATH BECAME DETACHED. THE PHYSICIAN AND HOSPITAL STAFF INFORMED THE ST. JUDE MEDICAL REP ON (B) (6)2009 THAT AN MRI OR CT WAS PERFORMED AND THE RADIOLOGIST DID NOT SEE THE TIP OF THE SHEATH IN THE RIGHT ATRIUM. AT THIS POINT, THE LOCATION OF THE DETACHED TIP IS UNK. IT SHOULD BE NOTED THAT THIS HOSPITAL PREVIOUSLY STORED THE DEVICES IN A PYXIS SYSTEM. THE ST. JUDE MEDICAL INSTRUCTIONS FOR USE STATE "STORE IN A COOL, DARK, DRY PLACE". THE PYXIS MACHINE IS NO LONGER BEING USED TO STORE THIS PRODUCT. THE ST. JUDE MEDICAL REP PERSONALLY VIEWED THE STORAGE AREA AND THE SHEATHS ARE NOW STORED IN A DRY DARK STORAGE CABINET. THIS DEVICE WAS MFG PRIOR TO IMPLEMENTATION OF A QUALITY IMPROVEMENT PROJECT TO INVESTIGATE UV ADHESIVE DEGRADATION OF BRAIDED SWARTZ INTRODUCERS. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED AS FOLLOWS "DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS DIFFICULT TO GET THROUGH THE SEPTUM. THE PHYSICIAN HAD TO PUSH A NUMBER OF TIMES AND WAS THEN ABLE TO CROSS THE SEPTUM. HE PERFORMED LEFT ATRIAL MAPPING AND ABLATED WITH NO PROBLEMS OR CONCERNS. HE PULLED BACK TO THE RIGHT ATRIUM (RA) AND USING THE SAME SHEATH, DID A TRICUSPID BURN AND VENA CAVA BURN. EVERYTHING WAS FINE WHEN HE FINISHED THE CASE. WHEN THE HOSP TECH REMOVED THE SHEATH, THE TIP OF THE SHEATH WAS NOTED TO BE MISSING. THE HEART WAS X-RAYED AND THE TIP WAS FOUND IN THE RIGHT ATRIUM. THE PHYSICIAN STATED, HE USED A WEBSTER NAVISTAR G CURVE 3.5MM IRRIGATION TIP ABLATION CATHETER. THE ST. JUDE MEDICAL REP THEN ASKED THE DOCTOR WHAT HIS PLAN OF RETRIEVAL WAS AND HE STATED THAT HE DID NOT THINK ABOUT THAT. THE PHYSICIAN AND HOSPITAL STAFF INFORMED THE ST. JUDE MEDICAL REP ON (B) (6)2009 THAT AN MRI OR CT WAS PERFORMED AND THE RADIOLOGIST DID NOT SEE THE TIP OF THE SHEATH IN THE RA. AT THIS POINT, THE LOCATION OF THE DETACHED TIP IS UNK. THE PHYSICIAN STATED THE PT DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM SWARTZ 8.5F, INTRO, SL0 DYB ST. JUDE MEDICAL, AF DIVISION NA 2681268

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other