BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND 300CM FLOPPY GUIDEWIRE

    MDR report key: 1092145 · Received August 1, 2008

    Report

    Report Number
    2939204-2008-00307
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV.
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UPN AND BATCH NUMBERS WERE NOT DISCLOSED. REPORT SOURCE. OTHER: INTERVENTIONAL NEURORADIOLOGY PEER REVIEW CONFERENCE. A SHIP HISTORY REVIEW IDENTIFIED THREE BATCHES THAT WERE SUPPLIED TO THE FACILITY IN THE LAST THREE YEARS. A DEVICE HISTORY RECORD REVIEW FOR ALL THREE BATCHES CONFIRMED THAT THEY MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECS. THE DEVICE WAS NOT RETURNED FOR EVAL. A REVIEW OF THE LABELING FOUND THAT IT CONTAINED LANGUAGE REGARDING THE REPORTED EVENT: "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ENDOVASCULAR PROCEDURES INCLUDE BUT NOT LIMITED TO: ANEURYSM RUPTURE; ACCESS SITE COMPLICATIONS INCLUDING INFECTION, HEMATOMA AND NERVE INJURY; CEREBRAL ISCHEMIA; DEATH; EMBOLISM (CATHETER/DEVICE, AIR BUBBLE, PLAQUE, THROMBUS OR CHAR); INTRACEREBRAL/INTRACRANIAL HEMORRHAGE; PSEUDOANEURYSM; SEIZURE; STROKE; TRANSIENT ISCHEMIC ATTACK; VASOSPASM AND VESSEL PERFORATION, DISSECTION, TRAUMA OR DAMAGE." THE CAUSE OF THE VESSEL PERFORATION COULD NOT BE DETERMINED WITH CERTAINTY BUT THERE IS NO ALLEGATION OR EVIDENCE OF PRODUCT MALFUNCTION OR NONCONFORMANCE. BASED ON THE INFO PROVIDED, THE MOST LIKELY CAUSE RELATES TO ANATOMICAL FACTORS SUCH AS THE NATURE OF THE ANEURYSM, SO A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN SELECTED.

    Description of Event or Problem · 1

    AT A PEER REVIEW CONFERENCE, IT WAS REPORTED THAT THE GUIDEWIRE WAS SUCCESSFULLY PLACED IN THE DISTAL MIDDLE CEREBRAL ARTERY (MCA). AS THE STENT SYSTEM WAS BEING ADVANCED TO THE MCA ANEURYSM, THE GUIDEWIRE BECAME BENT AND APPEARED TO HAVE ENGAGED IN A SMALL PERFORATOR VESSEL. THE STENT SYSTEM WAS RETRACTED INTO THE GUIDE CATHETER AND THE GUIDEWIRE WAS WITHDRAWN. ANGIOGRAPHY WAS TAKEN AND REVEALED A SMALL AMOUNT OF DYE EXTRAVASATION SUGGESTING A TINY VESSEL PERFORATION. HEPARIN WAS REVERSED AND THE STENT ASSISTED COILING OF THE ANEURYSM WAS COMPLETED WITHOUT FURTHER ISSUE USING A DIFFERENT GUIDEWIRE. THE PT WAS REPORTED TO HAVE SUFFERED A MINOR SUBARACHNOID HEMORRHAGE BUT MADE A GOOD RECOVERY. THE PHYSICIAN STATED THAT THE DISTAL TIP OF THE GUIDEWIRE FELT "STIFF" DURING USE. ADDITIONAL INFO WAS REQUESTED, BUT THERE IS NONE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND 300CM FLOPPY GUIDEWIRE (DQX) GUIDEWIRE DQX BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYNCHRO GUIDEWIRE| COILS| GUIDE CATHETER| BOSTON SCIENTIFIC NEUROFORM STENT