BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 CERE 6MMX26CM

    MDR report key: 11800981 · Received May 10, 2021

    Report

    Report Number
    3008114965-2021-00169
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 21, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528003021
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 21 JUNE 2021. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL (PC410062630 / K10342) REACHED THE TARGET POSITION, IT COULD NOT BE DETACHED. THE PHYSICIAN REMOVED IT FROM THE PATIENT¿S BODY AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT. THE PHOTO WAS REVIEWED BY THE PRODUCT ANALYSIS LAB. BASED ON THE PHOTO, THE EMBOLIC COIL WAS OBSERVED STILL ATTACHED, IT WAS PROTRUDING FROM THE INTRODUCER AND ENTANGLED WITH THE REST OF THE DEVICE. THERE WAS NO APPEARANCE OF DAMAGE NOTED ON THE DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 6MM X 26CM PRESIDIO 10 CERECYTE COIL WAS RETURNED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER. NO OTHER DAMAGES NOR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. MICROSCOPIC INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER. THERE WAS NO DAMAGE OBSERVED ON THE EMBOLIC COIL. THE PROTRUSION FROM THE INTRODUCER IS NOT RELATED WITH THE CUSTOMER REPORTED ISSUE THAT THE COIL FAILED TO DETACH. THE MICROSCOPIC INSPECTION FINDING IS CONSISTENT WITH THE PHOTO OF THE COMPLAINT DEVICE INCLUDED IN THE COMPLAINT; THE EMBOLIC COIL IN THE PHOTO WAS OBSERVED STILL ATTACHED TO THE DELIVERY SYSTEM BUT WAS NOTED TO BE PROTRUDING FROM THE INTRODUCER AND ENTANGLED WITH THE REST OF THE DEVICE. NO DAMAGE WAS OBSERVED ON THE COIL. FUNCTIONAL ANALYSIS: THE RETURNED COMPLAINT DEVICE UNDERWENT FUNCTIONAL EVALUATION. THE RESISTANCE OF THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL WAS MEASURED WITH A MULTIMETER. THE INITIAL RESISTANCE WAS MEASURED TO BE 53.2 O; THIS IS WITHIN THE SPECIFICATION RANGE OF 48.5 O ¿ 56.0 O. THE RETURNED COMPLAINT DEVICE WAS THEN CONNECTED TO A LAB SAMPLE ENPOWER CONTROL CABLE AND A DETACHMENT CONTROL BOX. THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT WAS ILLUMINATED. THE DETACH BUTTON WAS PRESSED AND THE EMBOLIC COIL DETACHED WITHOUT ANY ISSUE. THE REPORTED ISSUE THAT THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL COULD NOT BE DETACHED WHEN IT WAS DELIVERED TO THE TARGET POSITION WAS NOT CONFIRMED THROUGH FUNCTIONAL ANALYSIS AND EVALUATION PERFORMED ON THE RETURNED COMPLAINT DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10342) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: VERIFY THAT THE MICROCOIL DELIVERY SYSTEM IS FULLY CONNECTED, AND NO FAULTS ARE INDICATED ON THE DCB. IF A FAULT EXISTS, RESEAT ALL CONNECTIONS BETWEEN THE DPU, THE DCB, AND THE CONNECTING CABLE. IF A FAULT STILL PERSISTS, REPLACE THE CONNECTING CABLE. IF THIS DOES NOT CORRECT THE ERROR, REPLACE THE DCB. IF THE MICROCOIL DELIVERY SYSTEM STILL CONTINUES TO HAVE A FAULT, RETRIEVE THE MICROCOIL AS DESCRIBED IN THE FOLLOWING SECTION, RE SHEATHING THE MICROCOIL SYSTEM, AND REPLACE WITH A NEW MICROCOIL SYSTEM. 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. H.6: THE INVESTIGATION FINDINGS CODE OF ¿NO DEVICE PROBLEM FOUND (C19)¿ IS RELATED TO THE REPORTED ¿FAILURE TO DETACH¿ / ¿SEPARATION FAILURE (A150301)¿ ISSUE IN THE COMPLAINT. THIS ISSUE WAS NOT CONFIRMED BASED ON THE FUNCTIONAL EVALUATION AND ANALYSIS. THIS INVESTIGATION FINDING CODE CORRESPONDS TO THE INVESTIGATION CONCLUSION CODE ¿NO PROBLEM DETECTED (D14).¿ UPDATED SECTIONS: G.3, G.6, H.2, H.3, H.6, AND H.10. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. [PHOTO ANALYSIS]: THE PHOTO INCLUDED IN THE COMPLAINT FILE WAS REVIEWED BY THE PRODUCT ANALYSIS LAB; BASED ON THE PHOTO, THE EMBOLIC COIL WAS OBSERVED STILL ATTACHED, IT WAS PROTRUDING FROM THE INTRODUCER AND IS ENTANGLED WITH THE REST OF THE DEVICE. THERE WAS NO APPEARANCE OF DAMAGE NOTED ON THE DEVICE. FURTHER INVESTIGATION WILL BE PERFORMED WHEN THE COMPLAINT DEVICE IS RETURNED AND RECEIVED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10342) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL (PC410062630 / K10342) REACHED THE TARGET POSITION, IT COULD NOT BE DETACHED. THE PHYSICIAN REMOVED IT FROM THE PATIENT¿S BODY AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698431 PRESIDIO 10 CERE 6MMX26CM NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL PC4100626-30 K10342 00878528003021

    Patients

    Seq Age Sex Outcome Treatment
    1