BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 9365129 · Received November 22, 2019

    Report

    Report Number
    3005168196-2019-02156
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 22, 2019
    Report Date
    October 24, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013206
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2019-02156. 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2019-02152 2. 3005168196-2019-02153 3. 3005168196-2019-02154 4. 3005168196-2019-02155 5. 3005168196-2019-02157 6. 3005168196-2019-02158 7. 3005168196-2019-02159 8. 3005168196-2019-02164.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045 AND RESISTANCE WAS EXPERIENCED DURING BOTH ADVANCEMENT AND RETRACTION. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAIGHT TIP WAS HOUSING PART OF THE DETACHED COIL; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE DEVICES TOGETHER. HOWEVER, UPON REMOVAL, THE 8X60 RUBY COIL FULLY DETACHED AND BECAME IMPLANTED INTO THE PATIENT¿S EXTERNAL ILIAC ARTERY. THE 8X60 RUBY COIL WAS THEN REMOVED USING A SNARE DEVICE. THE PHYSICIAN CONTINUED THE PROCEDURE BY ADVANCING A PX SLIM 090 TO THE TARGET VESSEL, FOLLOWED BY AN 8X35 RUBY COIL. HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE 8X35 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 090. THEREFORE, THE 8X35 RUBY COIL AND PX SLIM 090 WERE REMOVED TOGETHER FROM THE PATIENT. SUBSEQUENTLY, A NON-PENUMBRA CATHETER WAS ADVANCED INTO THE TARGET VESSEL AND WAS SUCCESSFULLY USED TO IMPLANT TWO 10X35 RUBY COILS. UPON ADVANCEMENT OF A 8X35 RUBY COIL THROUGH THE NON-PENUMBRA CATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE PUSHER ASSEMBLY OF THE 8X35 RUBY COIL BROKE. THE 8X35 RUBY COIL WAS THEN REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS THEN ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2019-02152; 3005168196-2019-02153; 3005168196-2019-02154; 3005168196-2019-02155; 3005168196-2019-02157; 3005168196-2019-02158; 3005168196-2019-02159; 3005168196-2019-02164.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAIGHT TIP WAS HOUSING PART OF THE DETACHED COIL; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE DEVICES TOGETHER. HOWEVER, UPON REMOVAL, THE 8X60 RUBY COIL FULLY DETACHED AND BECAME IMPLANTED INTO THE PATIENT¿S EXTERNAL ILIAC ARTERY. THE 8X60 RUBY COIL WAS THEN REMOVED USING A SNARE DEVICE. THE PHYSICIAN CONTINUED THE PROCEDURE BY ADVANCING A PX SLIM 090 TO THE TARGET VESSEL, FOLLOWED BY AN 8X35 RUBY COIL. THE 8X35 RUBY COIL DID NOT ADVANCE THROUGH THE PX SLIM 090 AND THE PHYSICIAN DECIDED TO REMOVE THE 8X35 RUBY COIL AND PX SLIM 090 TOGETHER FROM THE PATIENT. SUBSEQUENTLY, A NON-PENUMBRA CATHETER (EXCELSIOR XT27) WAS ADVANCED INTO THE TARGET VESSEL AND WAS SUCCESSFULLY USED TO IMPLANT TWO 10X35 RUBY COILS. UPON ADVANCEMENT OF A 8X35 RUBY COIL THROUGH THE NON-PENUMBRA CATHETER (EXCELSIOR XT27), THE PHYSICIAN ENCOUNTERED DIFFICULTY AND THE PUSHER ASSEMBLY OF THE 8X35 RUBY COIL BROKE. DESPITE THE UNINTENTIONAL DETACHMENT, THE 8X35 RUBY COIL WAS SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL. THE PROCEDURE WAS THEN ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157352 RUBY COIL HCG, KRD HCG PENUMBRA, INC. RBY4C0835-A F91739 00814548013206

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR