BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT

    MDR report key: 22290431 · Received June 19, 2025

    Report

    Report Number
    3008114965-2025-00547
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 10, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    QJP
    PMA / PMN Number
    K210838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.4: THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE FULL UDI IS NOT AVAILABLE WITHOUT THE EXPIRATION DATE. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE PRODUCT ANALYSIS TEAM REVIEWED THE PHOTO OF THE COMPLAINT DEVICE. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: THE PHOTO INCLUDED IN IN THE COMPLAINT SHOWS A PORTION OF THE PROXIMAL SEGMENT OF THE MICROCATHETER. THE REST OF THE DEVICE IS CONTAINED WITHIN THE DISPENSER HOOP AND NOT VISIBLE. NO DAMAGE OR ANOMALIES ARE VISIBLE IN THE EXPOSED PORTION OF THE SHAFT. NO OTHER RELEVANT DETAILS CAN BE OBSERVED. THE LOT NUMBER WAS REPORTED AS UNAVAILABLE. AS A RESULT, THE MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE CONDUCTED. SHOULD THE CORRECT LOT NUMBER BE MADE AVAILABLE AT A LATER DATE, THE COMPLAINT FILE WILL BE REOPENED AND AN MRE REVIEW WILL BE PERFORMED AND DOCUMENTED. THE REPORTED COMPLAINT REGARDING AN OBSTRUCTED CATHETER CANNOT BE EVALUATED BY THE PICTURE ALONE AND THUS IS NOT CONFIRMED. THERE IS NOT ENOUGH INFORMATION TO DETERMINE ANY CONTRIBUTING FACTORS TO THE ISSUE EXPERIENCED. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTOS PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED PRODUCT ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION 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 LATER. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, 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. 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. 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 THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 08-JUL-2025. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.4, G.6. H.2, H.3, H.6, AND H.11. 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. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. NO APPEARANCE OF DAMAGES WAS OBSERVED. THE PRESENCE OF HYDROPHILIC COATING WAS CONFIRMED. MICROSCOPIC INSPECTION WAS PERFORMED ALONG THE BODY OF THE MICROCATHETER, AND NO DAMAGES WERE FOUND. THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) OF THE MICROCATHETER WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. THE ISSUE REGARDING THE STENT BEING IMPEDED IN THE HUB OF THE MICROCATHETER WAS CONFIRMED DURING THE X-RAY INSPECTION. IT IS SUGGESTED THAT IN AN ATTEMPT TO OVERCOME THE IMPEDED ISSUE ENCOUNTERED, THE STENT WAS PUSHED WITH A FORCE SUFFICIENT ENOUGH TO DISENGAGE THE STENT FROM THE DELIVERY SYSTEM AND IT REMAINED INSIDE THE MICROCATHETER. ACCORDING TO THE RISK DOCUMENTATION, THE INABILITY TO DELIVER A THERAPEUTIC DEVICE INTO THE MICROCATHETER IS A POTENTIAL FAILURE MODE THAT CAN OCCUR DUE TO USER TECHNIQUE. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. THE LOT NUMBER WAS REPORTED AS UNAVAILABLE. AS A RESULT, THE MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE PERFORMED. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE INSTRUCTION FOR USE (IFU) CONTAINS 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE POSTERIOR COMMUNICATING SEGMENT OF THE INTERNAL CAROTID ARTERY, WITH NO OBVIOUS TORTUOSITY OF THE BLOOD VESSEL, THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 9020399) WAS IMPEDED IN THE PROXIMAL END OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED THE DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO AND DOCUMENT THE FINDING. ON 18-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE POSTERIOR COMMUNICATING SEGMENT OF THE INTERNAL CAROTID ARTERY WITH NO OBVIOUS VESSEL TORTUOSITY. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE STENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. PER THE ADDITIONAL INFORMATION, WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS NO LONGER ON THE DELIVERY WIRE. THE STENT WAS STILL INSIDE THE MICROCATHETER. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE AND NO NEGATIVE IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639171 PROWLER SELECT CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDOS INTERNATIONAL SARL

    Patients

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