BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 5058624 · Received September 4, 2015

    Report

    Report Number
    2954740-2015-00203
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 31, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS VIEWED THROUGH THE RETURNED PACKAGING THE COIL WAS UNSHEATHED, STRETCHED, AND ENTANGLED. THE PROXIMAL SECTION OF THE COIL WAS STRETCHED WHICH APPEARS TO BE POST-PROCEDURAL IN NATURE. THE REMAINDER OF THE COIL IS UNDAMAGED. LOCATED 38.0 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE CORE WIRE PROTRUDES OUTSIDE THE SHEATH. NO MECHANICAL SHEATH DAMAGE RESULTING IN AN OPENED SKIVE WAS FOUND AT THE PROTRUSION SITE. NO MANUFACTURING DEFECTS WERE FOUND. THE MOST LIKELY CONTRIBUTING FACTOR TO THE RESHEATHING DIFFICULTY WAS DUE TO THE CORE WIRE PROTRUDING OUTSIDE THE SHEATH. IN THIS CONDITION RESHEATHING THE COIL CANNOT BE DETERMINED. THE CIRCUMSTANCES OF HOW AND WHEN THE CORE WIRE PROTRUDED OUTSIDE THE SHEATH CANNOT BE DETERMINED. DHR: 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 CAUSE OF THE UNREPORTED DAMAGE THAT THE COIL WAS ENTANGLED AND STRETCHED COULD NOT BE DETERMINED. IT IS PLAUSIBLE THAT THE ENTANGLEMENT OCCURRED UPON SHIPPING OR HANDLING AT SOME POINT AFTER THE COIL WAS EXPOSED AFTER IT COULD NOT BE RE-SHEATHED. HOWEVER THERE IS NO EVIDENCE OF A MANUFACTURING DEFECT AS REVIEW OF THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE CONTACT AT THE HOSPITAL REPORTED THAT DURING COIL EMBOLIZATION OF ABDOMINAL AORTIC ANEURYSM AT GASTRIC ARTERY THE PRESIDIO 18 COIL (C27883 /(B)(4)) COULD NOT BE RE-SHEATHED INTO THE INTRODUCER SHEATH. A SHEATH INTRODUCER BY TERUMO (MODEL UNKNOWN), A GW BY TERUMO (GT), A GC BY TERUMO (4FR), AND A MC BY TERUMO (PROGREAT ) WERE USED IN THIS PROCEDURE. IT WAS REPORTED THAT THE DEPLOYMENT SHEATH COULD NOT HOLD THE WIRE WHEN ATTEMPTING TO RE-SHEATH THE COMPLAINED COIL IN ORDER TO REPOSITION THE CATHETER. THREE DELTAMAXX COILS (DETAILS UNKNOWN) WERE ADDED LATER. THERE WERE NO FURTHER ISSUES OR DELAY, AND NO PATIENT INJURY/COMPLICATIONS. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO VISIBLE DAMAGE WAS NOTED ON THE PRODUCT PRIOR TO THE EVENT. THE COMPLAINT PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT ANALYSIS DISCOVERED THAT THE COIL WAS STRETCHED AND ENTANGLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587340 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC N/A C27883

    Patients

    Seq Age Sex Outcome Treatment
    1