BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKDELTAFILL

    MDR report key: 7948100 · Received October 9, 2018

    Report

    Report Number
    3008114965-2018-00765
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 20, 2018
    Report Date
    September 20, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). [COMPLAINT CONCLUSION]. AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRAVASCULAR COIL EMBOLIZATION OF A VEIN OF GALEN ANEURYSMAL MALFORMATION (VGM), THREE DELTAFILL18 THERMO-MECHANICAL COILS DID NOT DETACH CORRECTLY. THE ¿DETACH¿ BUTTON WAS PRESSED, BUT THE COIL FAILED TO DETACH, OR PERHAPS PARTIALLY DETACHED. THE PHYSICIAN HAD TO RETRACT THE COIL BACK INTO THE SL-10 (STRYKER) MICROCATHETER SEVERAL INCHES IN ORDER FOR IT TO FINALLY SEPARATE. THE PHYSICIAN THEN PUSHED THE COIL BACK INTO THE SPACE. THE PHYSICIAN CHANGED THE CONNECTING CABLE AND ENPOWER (DCB2000500/L12099) DETACHMENT CONTROL POINT DURING THE REPORTED EVENT, BUT THE ISSUE CONTINUED. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE USED TO DETACH SUBSEQUENT COILS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS DELAYED A MAXIMUM OF 30 SECONDS DUE TO THE EVENT. THE PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON ALL THE DEVICES. NEITHER A ¿LOW BATTERY¿ LIGHT NOR A ¿DEAD BATTERY¿ LIGHT WAS SEEN DURING THE CASE. A ¿FAULT¿ LIGHT WAS NOT VISUALIZED. UPON PRESSING THE ¿POWER¿ BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN ¿SYSTEM READY¿ LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE ¿DETACH CYCLE¿ LIGHT ILLUMINATED, AND THE INTERMITTENT SIGNAL TONE WAS HEARD. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE EMBOLIC COILS DID NOT APPEAR DAMAGED PRIOR TO THE EVENT. THE COIL DELIVERY SYSTEMS WERE PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE PROCEDURE. NO COILS WERE USED IN BETWEEN THE THREE COILS. THE SITE DOES NOT RECALL WHICH THREE OF THE SEVEN IMPLANTED DELTAFILL18 COILS EXPERIENCED THE ISSUE; HOWEVER, THE POTENTIAL CATALOG AND LOT NUMBERS ARE AS FOLLOWS: DLF182460/L11864 (QUANTITY OF 2), DLF181855/S11471 (QUANTITY OF 2), DLF182260/L11676 (QUANTITY OF 2), & DLF181650/S11470. EIGHT MICRUSFRAME S 18 COILS WERE PLACED WITHOUT INCIDENT; THEREFORE, A TOTAL OF 15 CERENOVUS THERMO-MECHANICAL COILS WERE IMPLANTED IN THE PATIENT DURING THE CASE. NO FURTHER INFORMATION WAS PROVIDED. THE DELTAFILL COIL REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH POTENTIAL LOTS L11864, S11471, L11676, & S11470 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT OF FAILURE TO DETACH COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEWS PERFORMED ON THE POTENTIAL LOTS, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. FAILURE TO DETACH IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT PRODUCT; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00764, 3008114965-2018-00765, & 3008114965-2018-00766.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). INFORMATION REGARDING PATIENT WEIGHT, RACE, AND ETHNICITY WAS NOT PROVIDED. PROCODE: KRD/HCG. (B)(4). CATALOG AND LOT: THE CUSTOMER DOES NOT RECALL WHICH THREE OF THE SEVEN IMPLANTED DELTAFILL18 COILS EXPERIENCED THE ISSUE; HOWEVER, THE POTENTIAL CATALOG AND LOT NUMBERS ARE AS FOLLOWS: DLF182460/L11864 (QUANTITY OF 2), DLF181855/S11471 (QUANTITY OF 2), DLF182260/L11676 (QUANTITY OF 2),AND DLF181650/S11470. DLF182460/L11864 - GTIN: (B)(4); MANUFACTURING DATE: 3/23/2018; EXPIRATION DATE: 2/28/2021, DLF181855/S11471 - GTIN: (B)(4); MANUFACTURING DATE: 7/22/2016; EXPIRATION DATE: 6/30/2019, DLF182260/L11676 - GTIN: (B)(4); MANUFACTURING DATE: 3/1/2018; EXPIRATION DATE: 2/28/2021, DLF181650/S11470 - GTIN: (B)(4); MANUFACTURING DATE 7/26/2016; EXPIRATION DATE: 6/30/2019. THE COILS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION AND TESTING. A MANUFACTURING REVIEW WILL BE PERFORMED ON THE POTENTIAL LOT NUMBERS PROVIDED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: ENPOWER DETACHMENT CONTROL BOX (DCB2000500/L12099), SL-10 (STRYKER) MICROCATHETER, EIGHT MICRUSFRAME S 18 COILS (MFR181750/S12529 (2), MFR181447/S11431, MFR182050/L10350 AND L12070 (2), MFR181550/L10827, AND MFR181647/L11590). INITIAL REPORTER OCCUPATION: DIRECTOR OF VASCULAR INTERVENTIONAL RADIOLOGY. (B)(4). THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00764, AND 3008114965-2018-00766.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRAVASCULAR COIL EMBOLIZATION OF A VEIN OF GALEN ANEURYSMAL MALFORMATION (VGM), THREE DELTAFILL18 THERMO-MECHANICAL COILS DID NOT DETACH CORRECTLY. THE ¿DETACH¿ BUTTON WAS PRESSED, BUT THE COIL FAILED TO DETACH OR PERHAPS PARTIALLY DETACHED. THE PHYSICIAN HAD TO RETRACT THE COIL BACK INTO THE SL-10 (STRYKER) MICROCATHETER SEVERAL INCHES IN ORDER FOR IT TO FINALLY SEPARATE. THE PHYSICIAN THEN PUSHED THE COIL BACK INTO THE SPACE. THE PHYSICIAN CHANGED THE CONNECTING CABLE AND ENPOWER (DCB2000500/L12099) DETACHMENT CONTROL POINT DURING THE REPORTED EVENT, BUT THE COILS STILL HAD DIFFICULTIES DETACHING. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE USED TO DETACH SUBSEQUENT COILS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS DELAYED A MAXIMUM OF 30 SECONDS DUE TO THE EVENT. THE PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON ALL OF THE DEVICES. NEITHER A ¿LOW BATTERY¿ LIGHT NOR A ¿DEAD BATTERY¿ LIGHT WAS SEEN DURING THE CASE. A ¿FAULT¿ LIGHT WAS NOT VISUALIZED. UPON PRESSING THE ¿POWER¿ BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN ¿SYSTEM READY¿ LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE ¿DETACH CYCLE¿ LIGHT ILLUMINATED, AND THE INTERMITTENT SIGNAL TONE WAS HEARD. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE EMBOLIC COILS DID NOT APPEAR DAMAGED PRIOR TO THE EVENT. THE COIL DELIVERY SYSTEMS WERE PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE PROCEDURE. NO COILS WERE USED IN BETWEEN THE THREE COILS. THE SITE DOES NOT RECALL WHICH THREE OF THE SEVEN IMPLANTED DELTAFILL18 COILS EXPERIENCED THE ISSUE; HOWEVER, THE POTENTIAL CATALOG AND LOT NUMBERS ARE AS FOLLOWS: DLF182460/L11864 (QUANTITY OF 2), DLF181855/S11471 (QUANTITY OF 2), DLF182260/L11676 (QUANTITY OF 2), AND DLF181650/S11470. EIGHT MICRUSFRAME S 18 COILS WERE PLACED WITHOUT INCIDENT; THEREFORE, A TOTAL OF 15 CERENOVUS THERMO-MECHANICAL COILS WERE IMPLANTED IN THE PATIENT DURING THE CASE. THE COMPLAINT COILS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790595 UNKDELTAFILL NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA