BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ CERE 3MMX6CM

    MDR report key: 7340898 · Received March 15, 2018

    Report

    Report Number
    3008114965-2018-00570
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    December 25, 2017
    Report Date
    December 26, 2017
    Product Code
    HCG
    UDI-DI
    00878528007197
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4) THE LOT COULD NOT BE OBTAINED. MANUFACTURER NAME/ PHYSICAL MANUFACTURER: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY AN AFFILIATE, THE COIL INTRODUCER WIRE OF A DELTAPAQ CERE COIL ((B)(4), UNKNOWN LOT) WAS KINKED. THERE WAS NO REPOT OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. PER THE FAILURE ANALYSIS LAB (FAL), THE EMBOLIC COIL IS STRETCHED. THERE HAVE BEEN MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THERE HAS BEEN NO INFORMATION PROVIDED. THE EMBOLIC COIL PASSES THROUGH THE RESHEATHING TOOL. THE EXTENDED COIL SECTION OF THE DEVICE POSITIONING UNIT (DPU) IS BENT IN TWO. THE DEVICE WAS GENTLY UNTANGLED. THERE ARE NO APPARENT KINKS OR BENDS IN THE DPU CORE WIRE. THE BALL TIP IS INTACT. THE EMBOLIC COIL PASSES INTO THE RESHEATHING TOOL. THE EMBOLIC COIL IS PARTIALLY UNSHEATHED; THE UNSHEATHED SECTION OF EMBOLIC COIL IS STRETCHED. THE STRETCHED SECTION OF EMBOLIC COIL EXITS THE PROXIMAL END OF THE RESHEATHING TOOL. THE ARTICULATING JOINT IS INTACT. THE RESISTANCE HEATING (RH) COIL HAS NOT HEATED. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. THE LOT NUMBER OF THE DEVICE IS UNKNOWN. WITHOUT THE LOT NUMBER, MANUFACTURING INFORMATION CANNOT BE REVIEWED. THE COMPLAINT THAT THE INTRODUCER IS KINKED OR BENT IS NOT CONFIRMED. THE GREEN INTRODUCER AND THE TRANSLUCENT INTRODUCER SHEATH ARE NOT KINKED OR BENT. HOWEVER, THE EXTENDED COIL SECTION OF THE DPU IS BENT AND THE EMBOLIC COIL IS UNSHEATHED AND STRETCHED. THE RESHEATHING TOOL HAS BEEN ADVANCED OVER THE EMBOLIC COIL, LIKELY WHILE UNSHEATHING THE DEVICE. THE IFU (LCN 51844-001 REV. B) INSTRUCTS THE USER TO UNSHEATHE A SMALL LENGTH OF THE DPU TO UNLOCK THE DEVICE, THEN TO ADVANCE THE EMBOLIC COIL INTO THE MICROCATHETER UNTIL THE HUB CONNECTOR OF THE DPU REACHES THE PROXIMAL END OF THE RESHEATHING TOOL. THIS RESULTS IN THE PLACEMENT OF THE EMBOLIC COIL AND THE MORE FLEXIBLE AND FRAGILE DISTAL SECTIONS OF THE DPU INSIDE THE MICROCATHETER BEFORE CONTINUING TO UNSHEATHE THE DEVICE. IF THE DEVICE IS UNSHEATHED BEFORE ADVANCING INTO THE MICROCATHETER, THERE IS A RISK THAT THE EMBOLIC COIL OR THE DISTAL END OF THE DPU WILL BE UNSHEATHED AND PASS THROUGH THE RESHEATHING TOOL. THIS CAN EXPOSE THE EMBOLIC COIL AND THE FLEXIBLE SECTIONS OF THE DPU, WHICH WILL THEN BE SUBJECT TO DAMAGE. STRETCHING OF THE EMBOLIC COIL MOST LIKELY OCCURRED AS IT WAS UNSHEATHED. THE UNSHEATHING ACTIVITY CAN PUT EXCESSIVE FORCE ON THE DEVICE, CAUSING IT TO STRETCH. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, THE COIL INTRODUCER WIRE OF A DELTAPAQ CERE COIL ((B)(4), UNKNOWN LOT) WAS KINKED. THERE WAS NO REPOT OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. PER THE FAILURE ANALYSIS LAB (FAL), THE EMBOLIC COIL IS STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186822 DELTAPAQ CERE 3MMX6CM NEUROVASCULAR EMBOLIZATION DEVICE HCG UNK 00878528007197

    Patients

    Seq Age Sex Outcome Treatment
    1