BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ 2.5MMX8CM SR PLAT

    MDR report key: 7712579 · Received July 23, 2018

    Report

    Report Number
    3008114965-2018-00686
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Report Date
    May 3, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    00878528007654
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (FREMONT). INITIAL REPORTER INFORMATION SUCH AS THE NAME, PHONE AND EMAIL ADDRESS ARE UNKNOWN. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 2.5MM X 8CM (DFS10025820 / P11442) WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED WITH THE LABEL FROM ITS INNER POUCH. INFORMATION ON THE LABEL MATCHES THE PRODUCT DOCUMENTED IN THE COMPLAINT. THE EMBOLIC COIL IS FULLY ADVANCED OUT OF THE INTRODUCER AND TANGLED AROUND THE DEVICE POSITIONING UNIT (DPU). THE DEVICE WAS CAREFULLY UNTANGLED. THE EXTENDED COIL SECTION OF THE DPU IS KINKED. THE DEVICE IS FULLY SHEATHED. THERE ARE NO APPARENT KINKS OR BENDS IN THE DPU CORE WIRE. THE BALL TIP IS INTACT. THE EMBOLIC COIL IS KINKED. THE PROXIMAL END OF THE EMBOLIC COIL IS STRETCHED. THE ARTICULATING JOINT IS INTACT. THE RESISTANCE HEATING (RH) COIL HAS NOT HEATED. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (P11442) 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. INVESTIGATION CONCLUSION: THE COMPLAINT THAT THE DEVICE IS DAMAGED IS CONFIRMED. THE EMBOLIC COIL IS KINKED AND STRETCHED. THE CIRCUMSTANCES SURROUNDING THE REPORTED EVENT ARE UNKNOWN. HOWEVER, STRETCHING IS GENERALLY CAUSED BY THE APPLICATION OF EXCESSIVE FORCE DURING RETRACTION WHEN RESISTANCE IS PRESENT. THE CAUSE OF THE RESISTANCE CANNOT BE IDENTIFIED FROM THE CONDITION OF THE RETURNED DEVICE. SINCE THE EMBOLIC COIL WAS ADVANCED OUT OF THE INTRODUCER AS RETURNED, IT IS ALSO POSSIBLE THAT SOME OF THE OBSERVED DAMAGE OCCURRED AFTER THE REPORTED EVENT, SUCH AS DURING STORAGE AND/OR SHIPPING. 100% OF DEVICES ARE INSPECTED FOR THE CONDITION OF THE EMBOLIC COIL DURING FINAL ASSEMBLY PER MPS-PRP0246 REV. 9. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE TO THE EMBOLIC COIL. 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. DEVICE HISTORY LOT ==> A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (P11442) 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 2.5MM X 8CM (DFS10025820 / P11442) WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554501 DELTAPAQ 2.5MMX8CM SR PLAT NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 P11442 00878528007654

    Patients

    Seq Age Sex Outcome Treatment
    1