BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 10670645 · Received October 13, 2020

    Report

    Report Number
    1820334-2020-01844
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Manufacturer
    COOK INC
    Product Code
    KRD
    PMA / PMN Number
    K151676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: (B)(6) HOSPITAL INFORMED COOK OF AN INCIDENT INVOLVING A RETRACTA DETACHABLE EMBOLIZATION COIL. WHILE USING REVERSE CURVE CATHETERS, DEPLOYING A RETRACTA COIL IS DIFFICULT. THE CUSTOMER STATED THAT THEY THOUGHT THIS WAS DUE TO A BUILDUP OF TENSION WITHIN THE CURVED CATHETER, KEEPING THE COIL FROM TWISTING OFF. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WERE 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. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY RELATED NONCONFORMANCE'S PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿THE RETRACTA DETACHABLE EMBOLIZATION COIL IS NOT RECOMMENDED FOR USE WITH POLYURETHANE CATHETERS OR CATHETERS WITH SIDEPORTS. IF A CATHETER WITH SIDEPORTS IS USED, THE EMBOLUS MAY LODGE IN THE SIDEPORT OR PASS INADVERTENTLY THROUGH IT. USE OF A POLYURETHANE CATHETER MAY ALSO RESULT IN LODGING OF THE EMBOLUS WITHIN THE CATHETER.¿ PRECAUTIONS: ¿PRIOR TO INTRODUCTION OF THE EMBOLIZATION COIL, FLUSH THE ANGIOGRAPHIC CATHETER WITH SALINE.¿ PRODUCT RECOMMENDATIONS: ¿THE FOLLOWING CATHETERS ARE RECOMMENDED FOR USE WITH RETRACTA DETACHABLE EMBOLIZATION COILS: HNB(R)4.0-35, HNB(R)5.0-35, HNB(R)5.0-38, SCBR-5.0-38, SCBR-4.0-38.¿ INSTRUCTIONS FOR USE: ¿UNDER FLUOROSCOPIC VISUALIZATION, SLOWLY ADVANCE THE DELIVERY WIRE UNTIL THE ENTIRE LENGTH OF THE COIL EXITS THE DISTAL END OF THE CATHETER. ENSURE THAT THE JUNCTION REMAINS POSITIONED JUST INSIDE THE CATHETER TIP. NOTE: ADVANCING THE DELIVERY WIRE SLOWLY ALLOWS THE JUNCTION TO BE SEEN MORE EASILY AND REDUCES THE RISK OF DAMAGING IT. NOTE: IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING COIL ADVANCEMENT, DO NOT CONTINUE ADVANCING. RETRACT THE DELIVERY WIRE SLIGHTLY, THEN GENTLY RE-ADVANCE IT. IF THERE IS STILL SIGNIFICANT RESISTANCE, WITHDRAW THE DELIVERY WIRE FROM THE CATHETER AND TRY USING A NEW COIL WITH A SHORTER LENGTH. IF THE COIL POSITION IS CORRECT, USE THE TORQUE DEVICE TO TURN THE DELIVERY WIRE COUNTERCLOCKWISE 8-10 TIMES, UNTIL THE COIL DETACHMENT CAN BE EITHER FELT OR VISUALIZED UNDER FLUOROSCOPY. NOTE: IT IS RECOMMENDED THAT THE JUNCTION REMAIN JUST INSIDE THE TIP OF THE CATHETER.¿ THE CUSTOMER DID NOT PROVIDE A LOT NUMBER OR SPECIFIC DEVICE RPN FOR THE INVESTIGATION. A SEARCH OF ALL LOTS SOLD TO THE CUSTOMER IN THE PAST THREE YEARS COULD NOT DETERMINE THE AFFECTED LOT. DUE TO THIS, COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OR A SEARCH FOR ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. AT THIS TIME AND DUE TO A REVIEW OF THE DEVICE MASTER RECORD, COOK CONCLUDES THAT NO NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. IT¿S POSSIBLE THAT THE CURVE IN THE CATHETER CAUSED THE COIL DELIVERY TO BE DIFFICULT, CREATING EXCESSIVE TORSION FORCES INHIBITING THE ROTATION OF THE DELIVERY WIRE. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, THIS COMPLAINT WILL BE TRENDED AS HUMAN FACTORS ENGINEERING - DEVICE DIFFICULT TO OPERATE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED RETRACTA DETACHABLE EMBOLIZATION COILS EXPERIENCE DIFFICULTY DEPLOYING WHEN USED WITH A CURVED CATHETER. THE OPERATOR REPORTED IT IS "AS THOUGH THE TWISTING FORCES TO DEPLOY ARE NOT BEING TRANSMITTED IN THE SAME WAY" AND THAT THERE "THERE APPEARS TO BE A BUILD UP OF TENSION" RESULTING IN DIFFICULTY KEEPING THE COIL DEPLOYMENT SYSTEM IN THE TARGET LOCATION. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135633 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1