BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 18MM X 55CM

    MDR report key: 7457259 · Received April 24, 2018

    Report

    Report Number
    3008114965-2018-00599
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 3, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704077152
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT WAS RECEIVED AND IS PENDING EVALUATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT ONCE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, AFTER THE CONTRAST CATHETER WAS ADVANCED FROM THE FEMORAL ARTERY, IT WAS PLACED AT THE INTROITUS PART OF THE LEFT INTERNAL ILIAC ARTERY (IIA). THE PROWLER SELECT PLUS MICROCATHETER (606S255FX / 17745485) WAS ADVANCED BUT DUE TO THE HEAVY TORTUOUSNESS OF THE INTROITUS PORTION FROM THE EXTERNAL ILIAC ARTERY (EIA) TO THE IIA, THE CONTRAST CATHETER BECAME WEDGED AND AS A RESULT, THE MICROCATHETER HAD DIFFICULTY ADVANCING BUT IT WAS EVENTUALLY PLACED WITH FORCE AT THE IIA. THE DELIVERY OF THE DELTAFILL18 18MM X 55CM (DLF181855 / S13470) WAS STARTED. FLUOROSCOPY WAS USED TO ENSURE THAT THE MARKER PASSES OVER THE HUB. THE COIL DELIVERY SYSTEM HAD DIFFICULTY AT THE LOCATION WHERE THE CONTRAST CATHETER BECAME WEDGED AND THE MICROCATHETER HAD DIFFICULTY WITH ADVANCEMENT WHEN IT WAS PASSING THROUGH. IT WAS NOT POSSIBLE TO DELIVER THE COIL AT THE TARGET SITE AS THE COIL CAME OUT AS ONE LOOP. STRONG RESISTANCE WAS FELT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE MICROCATHETER; THE COIL AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT AS A UNIT. WHEN THE DELIVERY WIRE WAS WITHDRAWN, IT WAS CONFIRMED THAT THE COIL HAD BECOME DETACHED IN THE MICROCATHETER. IT WAS CONFIRMED THAT NO COILS REMAINED IN THE PATIENT¿S BODY. A COMPETITIVE PUSHABLE COIL WAS USED TO REPLACE THE DELTAFILL 18 COIL; IT WAS PLACED USING THE CONTRAST CATHETER. A STENT GRAFT WAS PLACED WITHOUT ANY ISSUE AFTER THE PLACEMENT OF THE COMPETITIVE PUSHABLE COIL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. INVESTIGATION SUMMARY: SUMMARY: THE EMBOLIC COIL IS NOT ATTACHED AND WAS NOT RETURNED. THE SOFT DISTAL END OF THE DEVICE POSITIONING UNIT (DPU) IS KINKED. THE DEVICE IS FULLY UNSHEATHED AND FULLY ADVANCED. THE RESHEATHING TOOL HAS BEEN ADVANCED TO THE GREEN INTRODUCER. THERE ARE KINKS IN THE DPU CORE WIRE APPROXIMATELY 9 CM, 21 CM, 24 CM, 80 CM, 108 CM, 110 CM, 165 CM, AND 166 CM FROM THE PROXIMAL END. THE RH COIL HAS NOT HEATED. THERE IS BLOOD IN THE DISTAL OUTER SHEATH AT THE RH COIL AND EXTENDED COIL SECTIONS OF THE DPU. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. INVESTIGATION CONCLUSION: THE COMPLAINT OF POSITIONING DIFFICULTY IS SITUATIONALLY DEPENDENT AND CANNOT BE CONFIRMED IN THE LABORATORY. HOWEVER, THERE ARE SEVERAL BENDS OBSERVED IN THE DPU CORE WIRE, AND THESE COULD CONTRIBUTE TO DIFFICULTY WITH STEERING OR POSITIONING THE EMBOLIC COIL. THE COMPLAINT OF PREMATURE DETACHMENT IS CONFIRMED. THE EMBOLIC COIL IS DETACHED, AND THE RH COIL HAS NOT HEATED, INDICATING THAT THE COIL DETACHED MECHANICALLY. BENDS IN THE DPU CORE WIRE ARE INDICATIVE OF THE APPLICATION OF EXCESSIVE FORCE TO THE DEVICE, POSSIBLY IN AN ATTEMPT TO OVERCOME RESISTANCE WHERE THE CONTRAST CATHETER WAS REPORTEDLY WEDGED. MECHANICAL DETACHMENT IS ALSO GENERALLY INDICATIVE OF THE APPLICATION OF EXCESSIVE FORCE, OFTEN AS A DEVICE IS BEING RETRACTED AGAINST RESISTANCE. THE EMBOLIC COIL WAS NOT RETURNED. THUS, EVALUATION OF THE EMBOLIC COIL WAS NOT POSSIBLE. DEVICE HISTORY LOT: A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (S13470) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). CONCOMITANT MED PRODUCTS: PROWLER SELECT PLUS MICROCATHETER (606S255FX/17745485), ENPOWER CONTROL CABLE (ECB000182-00/S13941), DETACHMENT CONTROL BOX (DCB2000500), GUIDEWIRE (TERUMO RADIFOCUS 0.016), GUIDING CATHETER (RIM 5FR CONTRAST CATHETER). THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, AFTER THE CONTRAST CATHETER WAS ADVANCED FROM THE FEMORAL ARTERY, IT WAS PLACED AT THE INTROITUS PART OF THE LEFT INTERNAL ILIAC ARTERY (IIA). THE PROWLER SELECT PLUS MICROCATHETER (606S255FX / 17745485) WAS ADVANCED BUT DUE TO THE HEAVY TORTUOUSNESS OF THE INTROITUS PORTION FROM THE EXTERNAL ILIAC ARTERY (EIA) TO THE IIA, THE CONTRAST CATHETER BECAME WEDGED AND AS A RESULT, THE MICROCATHETER HAD DIFFICULTY ADVANCING BUT IT WAS EVENTUALLY PLACED WITH FORCE AT THE IIA. THE DELIVERY OF THE DELTAFILL18 18MM X 55CM (DLF181855 / S13470) WAS STARTED. FLUOROSCOPY WAS USED TO ENSURE THAT THE MARKER PASSES OVER THE HUB. THE COIL DELIVERY SYSTEM HAD DIFFICULTY AT THE LOCATION WHERE THE CONTRAST CATHETER BECAME WEDGED AND THE MICROCATHETER HAD DIFFICULTY WITH ADVANCEMENT WHEN IT WAS PASSING THROUGH. IT WAS NOT POSSIBLE TO DELIVER THE COIL AT THE TARGET SITE AS THE COIL CAME OUT AS ONE LOOP. STRONG RESISTANCE WAS FELT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE MICROCATHETER; THE COIL AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT AS A UNIT. WHEN THE DELIVERY WIRE WAS WITHDRAWN, IT WAS CONFIRMED THAT THE COIL HAD BECOME DETACHED IN THE MICROCATHETER. IT WAS CONFIRMED THAT NO COILS REMAINED IN THE PATIENT¿S BODY. A COMPETITIVE PUSHABLE COIL WAS USED TO REPLACE THE DELTAFILL 18 COIL; IT WAS PLACED USING THE CONTRAST CATHETER. A STENT GRAFT WAS PLACED WITHOUT ANY ISSUE AFTER THE PLACEMENT OF THE COMPETITIVE PUSHABLE COIL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299443 DELTAFILL18 18MM X 55CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 S13470 10886704077152

    Patients

    Seq Age Sex Outcome Treatment
    1