BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT

    MDR report key: 22245714 · Received June 17, 2025

    Report

    Report Number
    3008114965-2025-00524
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 9, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    QJP
    UDI-DI
    10886704028888
    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 E.1: THE INITIAL REPORTER PHONE: (B)(6). SECTION H.3: 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. THE PRODUCT ANALYSIS TEAM REVIEWED THE PHOTOS OF THE COMPLAINT DEVICES. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: THE PHOTOS SHOW THE MICROCATHETER COILED UP WITH THE FULL LENGTH VISIBLE. A SLIGHT KINK CAN BE OBSERVED NEAR THE DISTAL RIP OF THE CATHETER. NO OTHER RELEVANT DETAILS CAN BE OBSERVED. THE REPORTED ISSUE IN THE COMPLAINT REGARDING THE KINKED CATHETER CAN BE CONFIRMED BASED ON THE CONDITION OBSERVED IN THE PHOTOS. THE REPORTED COMPLAINT REGARDING AN OBSTRUCTED CATHETER CANNOT BE EVALUATED ONLY BASED ON THE PHOTOS BUT IS CONSISTENT WITH THE KINK IN THE DISTAL SHAFT OBSERVED. 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. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31432570) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO INTERNAL ACTIONS RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. THERE WERE THREE COMPRESSED AREAS OBSERVED AT THE DISTAL TIP OF THE MICROCATHETER. THE DAMAGES WERE NOTED FROM 2.7 CM TO 3.1 CM. THE PRESENCE OF HYDROPHILIC COATING WAS CONFIRMED. THE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE; HOWEVER, HIGH RESISTANCE WAS MET, NO WATER WAS COMING OUT OF THE DISTAL TIP. AN 0.018-INCH GUIDEWIRE WAS ADVANCED THROUGH THE MICROCATHETER; HOWEVER, THE GUIDEWIRE WAS STUCK AT 67CM. THE AREA WAS DISSECTED, AND THE SHAFT WAS FOUND OCCLUDED WITH A COAGULUM. THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) OF THE MICROCATHETER WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. THE ISSUES REPORTED REGARDING THE MICROCATHETER BEING KINKED AND OBSTRUCTED WAS CONFIRMED BASED ON THE COMPRESSED CONDITIONS AND COAGULUM FOUND INSIDE THE MICROCATHETER. ACCORDING TO THE RISK DOCUMENTATION, THE INABILITY TO DELIVER THE THERAPEUTIC DEVICE OR TRACK THE GUIDEWIRE TO DESIRE LOCATION IS A POTENTIAL ISSUE THAT CAN OCCUR DURING THE INSERTION OF THE MICROCATHETER INTO THE RHV OF GUIDING / INTERMEDIATE CATHETER OR SHEATH AND CAN RESULT IN THE MICROCATHETER GETTING DAMAGED OR KINKED DURING USE. ADDITIONALLY, THE COAGULUM FOUND SUGGESTS THAT THE SALINE FLUSH MAY HAVE BEEN INSUFFICIENT, AND ACCORDING TO RISK DOCUMENTATION, INSUFFICIENT FLUSHING CAN LEAD TO THE MICROCATHETER TO BECOME UNUSABLE. THE INSTRUCTION FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS TO PREVENT SUCH ISSUE FROM OCCURRING. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT: (31432570) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO INTERNAL ACTIONS RELATED TO DEVICE MANUFACTURE OR INSPECTION. 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. UPDATED SECTIONS: B.4, G.3, 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.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE START OF AN ANGIOPLASTY PROCEDURE, THE DEVICE PACKAGING FOR THE DEVICES WERE INSPECTED AND FOUND TO BE IN GOOD CONDITION. DURING THE PROCEDURE, THE 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 9061884) WAS IMPEDED IN THE DISTAL END OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31432570) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT FROM THE PATIENT. WHILE RETRACTING THE STENT FROM THE MICROCATHETER, THE STENT COMPONENT WAS FOUND TO HAVE PREMATURELY DETACHED FROM THE DELIVERY WIRE AFTER THE STENT WAS OUT OF THE MICROCATHETER. IT WAS ALSO NOTED THAT THE TIP OF THE DELIVERY WIRE AND THE DISTAL END OF THE MICROCATHETER WERE KINKED / BENT. THE DEVICES WERE REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 12-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE REPLACEMENT DEVICES WERE ANOTHER 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312) AND ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO PROCEDURE DELAY AND NO NEGATIVE PATIENT IMPACT. PHOTOS OF THE COMPLAINT DEVICES WERE INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590399 PROWLER SELECT CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDOS INTERNATIONAL SARL 31432570 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENTERPRISE2 4MMX23MM.