BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM CATHETER

    MDR report key: 8285508 · Received January 29, 2019

    Report

    Report Number
    2939520-2019-00019
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    October 18, 2018
    Report Date
    October 19, 2018
    Manufacturer
    PHILIPS VOLCANO
    Product Code
    OBJ
    UDI-DI
    00845225001339
    PMA / PMN Number
    K143701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    BLOCK H6: SUPPLEMENTAL REPORT #1 INDICATED THAT THE ADHESIVE LIKELY DETACHED POST PROCEDURE; HOWEVER, THE CONCLUSION CODE WAS NOT UPDATED FROM 4315 (CAUSE NOT ESTABLISHED) TO 4308 (CAUSE TRACED TO TRANSPORT/STORAGE).

    Description of Event or Problem · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. INTERNAL REFERENCE: (B)(4). THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO REPORT ADDITIONAL INVESTIGATION FINDINGS, TO WIT: THERE IS NO POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR. THIS COMPLAINT WAS REASSESSED BASED ON AN ENGINEERING STUDY THAT INDICATED, THIS FAMILY OF CATHETERS DO NOT EXHIBIT ANY ADHESIVE DETACHMENT DURING NORMAL USE. THERE IS NO EVIDENCE OF ABNORMAL USE CONDITIONS, IT IS LIKELY THE ADHESIVE DETACHED POST-PROCEDURE, DURING THE PROCESS OF RETURNING THE DEVICE FOR ANALYSIS. THERE WAS NO PATIENT INJURY, NO STATUS DECLINE, NO ADVERSE EVENT, AND NO UNPLANNED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REPORTED. THERE IS NO POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE: (B)(4). FACILITY DECLINED TO PROVIDE PATIENT INFORMATION OF ID, GENDER, AGE AND WEIGHT. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. CONCOMITANT MEDICAL PRODUCTS: NO INFORMATION AVAILABLE. STATE/PREFECTURE IS (B)(6). INSERT INVESTIGATION FINDINGS AND APPROPRIATE CASE DETAILS HERE.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A PLANNED THERAPEUTIC CORONARY PROCEDURE, INSIDE THE BODY, TRACKING OVER THE HORN, THE IMAGE ON THE MANUFACTURE'S DEVICE DISAPPEARED. THERE IS NO PATIENT INJURY. ACCESS LOCATION; FEMORAL, CALCIFICATION; NONE. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED AND DAMAGE WAS OBSERVED. A PORTION OF THE ADHESIVE AT THE PROXIMAL FILLET, A PORTION OF THE ADHESIVE AT THE DISTAL FILLET, AND A PORTION OF KAPTON SCANNER MATERIAL WERE MISSING. THE PZT ARRAY WAS SCRATCHED. THE PROBABLE CAUSE OF THE OBSERVED MISSING ADHESIVE AND KAPTON SCANNER MATERIAL IS DAMAGE, AS EVIDENCED BY THE SCRATCHES PRESENT AT THE DISTAL FILLET, PROXIMAL FILLET, AND PZT ARRAY. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE PORTIONS OF THE MANUFACTURE'S DEVICE WERE MISSING. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79794 EAGLE EYE PLATINUM CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILIPS VOLCANO 85900PJ 301476828 00845225001339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown