BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS

    MDR report key: 20687861 · Received November 14, 2024

    Report

    Report Number
    3008114965-2024-01113
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    November 2, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRA
    UDI-DI
    10886704028888
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9020399) BECAME IMPEDED IN MICROCATHETER HUB OF A PROWLER SELECT PLUS 150/5CM (606S255X, 31351018) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-NOV-2024 INDICATING THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS NOT DELAYED DUE TO THE EVENT. ONE PHOTO ACCOMPANIED THE COMPLAINT FILE IN WHICH A STENT COMPONENT CAN BE SEEN OUTSIDE THE INTRODUCER AND DETACHED IN THE DELIVERY WIRE. THE STENT WAS OBSERVED TO BE IN GOOD CONDITION; THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS); ALSO, IT WAS NOTED FULLY EXPANDED, BOTH ENDS CAN BE NOTED AS COMPLETELY FLARED. THE LUER HUB AND PORTIONS OF THE SHAFT OF THE MICROCATHETER ARE SHOWN IN THE PHOTO; HOWEVER, NO DAMAGES CAN BE SEEN. A NON-STERILE PROWLER SELECT PLUS 150/5CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO APPEARANCE OF DAMAGES WAS OBSERVED. THE PRESENCE OF HYDROPHILIC COATING WAS CONFIRMED. THE MICROCATHETER WAS FLUSHED USING A LAB-SAMPLE SYRINGE, THEN A LAB-SAMPLE GUIDEWIRE WAS INTRODUCED INTO THE RECEIVED MICROCATHETER AND WAS ABLE TO BE ADVANCED THROUGH THE ENTIRE LENGTH OF THE MICROCATHETER WITHOUT NOTICEABLE RESISTANCE. THE MICROCATHETER WAS CONFIRMED TO BE WITHIN SPECIFICATIONS FOR THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31351018 NUMBER, AND NO NON-CONFORMANCE'S RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE LAB SAMPLE GUIDE WIRE WAS ABLE TO PASS THROUGH THE ENTIRE LENGTH OF THE GUIDE CATHETER WITHOUT SIGNIFICANT RESISTANCE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED WITH THE EVIDENCE AVAILABLE. IT IS POSSIBLE THAT OTHER CLINICAL AND PROCEDURAL FACTORS THAT CANNOT BE REPLICATED DURING THE ANALYSIS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. ADDITIONALLY, NO OTHER DAMAGES WERE FOUND ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE ISSUE REPORTED DURING THE PROCEDURE. AS PART OF J&J MEDTECH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CAPA ACTIVITY IS REQUIRED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING CAUTION: IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER AND GUIDEWIRE AS A SYSTEM. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION E1. INITIAL REPORTER PHONE: (B)(6). SECTION H3 - THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. ONE PHOTO ACCOMPANIED THE COMPLAINT FILE IN WHICH A STENT COMPONENT CAN BE SEEN OUTSIDE THE INTRODUCER AND DETACHED IN THE DELIVERY WIRE. THE STENT WAS OBSERVED TO BE IN GOOD CONDITION; THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS); ALSO, IT WAS NOTED FULLY EXPANDED, BOTH ENDS CAN BE NOTED AS COMPLETELY FLARED. THE LUER HUB AND PORTIONS OF THE SHAFT OF THE MICROCATHETER ARE SHOWN IN THE PHOTO; HOWEVER, NO DAMAGES CAN BE SEEN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31351018 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE STENT BEING IMPEDED IN THE MICROCATHETER HUB DUE TO THE MICROCATHETER BEING OCCLUDED CANNOT BE EVALUATED THROUGH A PHOTO, A FUNCTIONAL ANALYSIS MUST BE PERFORMED TO DETERMINE A ROOT CAUSE. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9020399) BECAME IMPEDED IN MICROCATHETER HUB OF A PROWLER SELECT PLUS 150/5CM (606S255X, 31351018) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-NOV-2024 INDICATING THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS NOT DELAYED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224663 PROWLER SELECT PLUS CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 31351018 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EU ENT4.5MMD 22MML WNO DSTL TP.