BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - CERECYTE MICROCOIL

    MDR report key: 6106451 · Received November 16, 2016

    Report

    Report Number
    2954740-2016-00275
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528004400
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 11/16/2016 INDICATING THE DEVICE COULD NOT BE RETURNED FROM THE CUSTOMER. AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM, THE CASHMERE COIL (CRC14022530/C25010) COULD NOT BE SHAPED COMPLETELY. THERE WAS DIFFICULTY GETTING THE COIL TO CONFORM TO THE WALL OF THE ANEURYSM. THEY WITHDREW THE COIL WITHOUT DIFFICULTY AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THIS WAS THE FIRST COIL TO BE IMPLANTED. THERE WAS NO REPORT OF RESISTANCE BETWEEN THE CASHMERE AND THE UNSPECIFIED MICROCATHETER. AFTER REMOVAL OF THE COIL FROM THE PATIENT, IT DID NOT APPEAR DAMAGED (I.E. STRETCHED, KINKED COMPRESSED, SEPARATED OR DETACHED). THERE WAS NO REPORT OF PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, IT WAS LATER REPORTED THAT THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE INABILITY OF THE COIL TO CONFIRM TO THE WALL OF THE ANEURYSM COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, PROCEDURAL FACTORS OR ANEURYSM CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS ON 12/21/2016. CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM, THE CASHMERE COIL (CRC14022530/C25010) COULD NOT BE SHAPED COMPLETELY. THERE WAS DIFFICULTY GETTING THE COIL TO CONFORM TO THE WALL OF THE ANEURYSM. THEY WITHDREW THE COIL WITHOUT DIFFICULTY AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THIS WAS THE FIRST COIL TO BE IMPLANTED. THERE WAS NO REPORT OF RESISTANCE BETWEEN THE CASHMERE AND THE UNSPECIFIED MICROCATHETER. AFTER REMOVAL OF THE COIL FROM THE PATIENT, IT DID NOT APPEAR DAMAGED (I.E. STRETCHED, KINKED COMPRESSED, SEPARATED OR DETACHED). THERE WAS NO REPORT OF PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE UNIDENTIFIED MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE WERE NOT RETURNED. CONCERNING CLEANLINESS ONLY, THE MICROCOIL SYSTEM WAS RETURNED IN ALMOST PRISTINE CONDITION. THE COIL WAS RETURNED UNDAMAGED AND IN THE CORRECT SECONDARY SHAPING. NO MANUFACTURING DEFECTS WERE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT THE COMPLAINT OF THE COILS POSITIONING OR SHAPING DIFFICULTY INSIDE THE TARGET SITE WAS NOT CONFIRMED. THE COIL WAS RETURNED UNDAMAGED AND IN THE CORRECT SECONDARY SHAPING, THEREFORE THE ROOT CAUSE OF THE COIL UNABLE TO BE SHAPED CORRECTLY INSIDE THE TARGET SITE CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE TARGETS DIMENSIONS, FILM, THE IDENTIFICATION OF THE SECOND COIL UTILIZED, THE IDENTIFICATION OR RETURN OF THE UNKNOWN MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. ANEURYSM CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM, THE CASHMERE COIL (CRC14022530/C25010) COULD NOT BE SHAPED COMPLETELY. THERE WAS DIFFICULTY GETTING THE COIL TO CONFORM TO THE WALL OF THE ANEURYSM. THEY WITHDREW THE COIL WITHOUT DIFFICULTY AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THIS WAS THE FIRST COIL TO BE IMPLANTED. THERE WAS NO REPORT OF RESISTANCE BETWEEN THE CASHMERE AND THE UNSPECIFIED MICROCATHETER. AFTER REMOVAL OF THE COIL FROM THE PATIENT, IT DID NOT APPEAR DAMAGED (I.E. STRETCHED, KINKED COMPRESSED, SEPARATED OR DETACHED). THERE WAS NO REPORT OF PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759045 CASHMERE 14 - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA C25010 00878528004400

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR