BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFORM SUPER COMPLIANT 4MM X 7MM

    MDR report key: 4967239 · Received August 4, 2015

    Report

    Report Number
    3008853977-2015-00328
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK (MDR)
    Product Code
    MJN
    PMA / PMN Number
    K122576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS DISPOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT SALINE AND NOT CONTRAST WAS USED TO INFLATE THE BALLOON. IT IS LIKELY THAT THE USER OVERINFLATED THE BALLOON AS IT COULD NOT BE VISUALIZED DUE TO THE LACK OF CONTRAST WHICH RESULTED IN THE REPORTED EVENT. THEREFORE A CAUSE OF USER ERROR HAS BEEN ASSIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL PART OF THE 15TH COIL PROTRUDED FROM THE UNRUPTURED INTERNAL CAROTID - POSTERIOR COMMUNICATING (IC-PC) ARTERY ANEURYSM. A BALLOON (SUBJECT DEVICE) WAS INFLATED IN ORDER TO PUSH THE COIL COMPLETELY INTO THE ANEURYSM. BALLOON INFLATION CONTINUED AS THERE WAS DIFFICULTY VISUALIZING THE BALLOON UNDER FLUOROSCOPY AT WHICH POINT THE VESSEL DISSECTED. SUBARACHNOID HEMORRHAGE OCCURRED AS A RESULT OF THE VESSEL DISSECTION AND THE TRUNK OF THE INTERNAL CAROTID ARTERY WAS FILLED WITH COIL. THE PATIENT'S BRAIN PRESSURE INCREASED WHICH WAS TREATED VIA CRANIOTOMY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN INFLATED THE BALLOON WITH SALINE INSTEAD OF CONTRAST. IT WAS REPORTED THAT THE PATIENT HAS NOT RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL PART OF THE 15TH COIL PROTRUDED FROM THE UNRUPTURED INTERNAL CAROTID - POSTERIOR COMMUNICATING (IC-PC) ARTERY ANEURYSM. A BALLOON (SUBJECT DEVICE) WAS INFLATED IN ORDER TO PUSH THE COIL COMPLETELY INTO THE ANEURYSM. BALLOON INFLATION CONTINUED AS THERE WAS DIFFICULTY VISUALIZING THE BALLOON UNDER FLUOROSCOPY AT WHICH POINT THE VESSEL DISSECTED. SUBARACHNOID HEMORRHAGE OCCURRED AS A RESULT OF THE VESSEL DISSECTION AND THE TRUNK OF THE INTERNAL CAROTID ARTERY WAS FILLED WITH COIL. THE PATIENT'S BRAIN PRESSURE INCREASED WHICH WAS TREATED VIA CRANIOTOMY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN INFLATED THE BALLOON WITH SALINE INSTEAD OF CONTRAST. IT WAS REPORTED THAT THE PATIENT HAS NOT RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL PART OF THE 15TH COIL PROTRUDED FROM THE UNRUPTURED INTERNAL CAROTID - POSTERIOR COMMUNICATING (IC-PC) ARTERY ANEURYSM. A BALLOON (SUBJECT DEVICE) WAS INFLATED IN ORDER TO PUSH THE COIL COMPLETELY INTO THE ANEURYSM. BALLOON INFLATION CONTINUED AS THERE WAS DIFFICULTY VISUALIZING THE BALLOON UNDER FLUOROSCOPY AT WHICH POINT THE VESSEL DISSECTED. SUBARACHNOID HEMORRHAGE OCCURRED AS A RESULT OF THE VESSEL DISSECTION AND THE TRUNK OF THE INTERNAL CAROTID ARTERY WAS FILLED WITH COIL. THE PATIENT'S BRAIN PRESSURE INCREASED WHICH WAS TREATED VIA CRANIOTOMY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN INFLATED THE BALLOON WITH SALINE INSTEAD OF CONTRAST. IT WAS REPORTED THAT THE PATIENT HAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506249 TRANSFORM SUPER COMPLIANT 4MM X 7MM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN STRYKER NEUROVASCULAR CORK (MDR) 18284734

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R