BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7498139 · Received May 9, 2018

    Report

    Report Number
    1820334-2018-01139
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    March 24, 2015
    Report Date
    August 2, 2018
    Manufacturer
    COOK INC
    Product Code
    DXE
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. - ATTACHMENT: [SHAPIRO_FOREIGN BODY EMBOLI FOLLOWING CEREBROVASCULAR INTERVENTIONS.PDF].

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO SECTION H10 FOR INVESTIGATIONAL FINDINGS.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, OR UNAVAILABLE. COMMON NAME & PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. OTHER MANUFACTURER'S DEVICES: DIAGNOSTIC CATHETER -5F VER ,DIAGNOSTIC WIRE-038, EXCHANGE WIRE- WHOLEY EXCHANGE, SHEATH -SHUTTLE 5F, SECOND CATHETER -ENVOY , DISTAL SUPPORT CATHETER -NAVIEN 058, MICROCATHETER -MARKSMAN-150, MICROCATHETER, OTHER- ECHELON-10, MICROWIRE- TRANSEND 014PLATINUM, DEVICES- PIPELINE 4.5 X 14, COILS -TARGET. (B)(4). PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. SHAPIRO ET. AL, (2015),FOREIGN BODY EMBOLI FOLLOWING CEREBROVASCULAR INTERVENTIONS: CLINICAL, RADIOGRAPHIC, AND HISTOPATHOLOGIC FEATURES, VOL.36 PP 2121-2126, AJNR, RETRIEVED FROM: WWW.AJNR.ORG

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED TITLED "FOREIGN BODY EMBOLI FOLLOWING CEREBROVASCULAR INTERVENTIONS: CLINICAL, RADIOGRAPHIC, AND HISTOPATHOLOGIC FEATURES" WHICH STATED: "FOREIGN MATERIAL EMBOLI FOLLOWING CEREBRAL, CARDIAC, AND PERIPHERAL CATHETERIZATIONS HAVE BEEN REPORTED SINCE THE MID-1990S. CATHETER COATINGS HAVE BEEN FREQUENTLY IMPLICATED. THE MOST RECENT SURGE OF INTEREST IN THIS PHENOMENON WITHIN THE NEUROINTERVENTIONAL COMMUNITY IS ASSOCIATED WITH PROCEDURES USING FLOW-DIVERSION DEVICES FOR THE TREATMENT OF CEREBRAL ANEURYSMS." THE ARTICLE INCLUDED CASE STUDIES AND 4 OF THE CASE STUDIES INCLUDED PATIENTS THAT UNDERWENT PROCEDURES WHERE COOK DEVICES WERE USED. THE AUTHOR REPORTED, PATIENT 1 UNDERWENT UNREMARKABLE COIL-SUPPORTED EMBOLIZATION OF AN INCIDENTAL RIGHT TRIGEMINAL ANEURYSM USING DUAL-GROIN ACCESS; THE EMBOLIZATION DEPLOYMENT DEVICE AXIS CONSISTED OF 5F SHUTTLE (COOK, BLOOMINGTON, INDIANA), AND TWO OTHER MANUFACTURER'S CATHETERS. THE PATIENT FELT PERSISTENTLY TIRED DURING THE SUBSEQUENT EIGHT WEEKS, FOLLOWED BY DEVELOPMENT OF LEFT-SIDED WEAKNESS AND LEFT HOMONYMOUS QUADRANTANOPSIA. COMPUTED TOMOGRAPHY (CT) SHOWED MULTIFOCAL RIGHT-HEMISPHERE EDEMA. MAGNETIC RESONANCE (MR) IMAGING DEMONSTRATED MULTIPLE SUBCENTIMETER LESIONS, PREDOMINANTLY WITHIN THE SUBCORTICAL WHITE MATTER AND AT THE GRAY-WHITE JUNCTIONS. MOST LESIONS SHOWED BOTH MAGNETIC SUSCEPTIBILITY AND ENHANCEMENT. NONE HAD RESTRICTED DIFFUSION, AND ALL WERE SURROUNDED BY EXTENSIVE VASOGENIC EDEMA. EMPIRIC SIX-WEEK ANTIBIOTIC TREATMENT WAS UNDERTAKEN CONCURRENTLY WITH A TWO MONTH COURSE OF DEXAMETHASONE. ALL NEUROLOGIC SYMPTOMS RESOLVED IN FOUR WEEKS. SERIAL MR IMAGING SHOWED NEAR-RESOLUTION OF THE EDEMA. ALL LESIONS CONTINUE TO ENHANCE. CURRENTLY, THE EXTENT OF MAGNETIC SUSCEPTIBILITY IS UNCHANGED, AND NO NEW LESIONS HAVE DEVELOPED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. REFER TO MEDWATCHES WITH MANUFACTURER REPORT NUMBERS AS FOLLOWS FOR THE OTHER CASES: 1820334-2018-01140, 1820334-2018-01277, 1820334-2018-01278.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342003 UNKNOWN DXE COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R