BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT

    MDR report key: 23726500 · Received December 5, 2025

    Report

    Report Number
    3008114965-2025-01380
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 30, 2025
    Report Date
    January 14, 2026
    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 REF#: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. 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. 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 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

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 28MMD ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9242468) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: 31586954) AND COULD NOT ADVANCE ANY MORE. THEY ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF Y CONNECTOR. THE DOCTOR SWITCHED A SECOND NEW STENT, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452812, LOT NUMBER: 9616877), BUT THIS SECOND STENT WAS ALSO IMPEDED IN THE MIDDLE SECTION OF THE ORIGINAL MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE SECOND STENT, THE SECOND STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE ORIGINAL MICROCATHETER. THE DOCTOR REMOVED THE SECOND STENT AND THE ORIGINAL MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO A SECOND NEW MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (PRODUCT CODE: 606S255X, LOT NUMBER: 31626342). A THIRD STENT, A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9924736) ALSO IMPEDED IN THE MIDDLE SECTION OF THE SECOND MICROCATHETER. THE DOCTOR REMOVED THE SECOND MICROCATHETER AND THE THIRD STENT FROM THE PATIENT AND SWITCHED OUT TO NEW DEVICES (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR ADVERSE IMPACT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-DEC-2025 INDICATED THAT THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THERE WERE NO VESSELS OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENTS. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO APPEARANCE OF DAMAGES WAS OBSERVED. 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). THE LAB SAMPLE GUIDE WIRE WAS ABLE TO PASS THROUGH THE ENTIRE LENGTH OF THE MICROCATHETER 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 DAMAGES WERE FOUND ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE ISSUE REPORTED DURING THE PROCEDURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31586954 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE MALFUNCTION WERE IDENTIFIED. 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 INTERNAL ACTION 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 28MMD ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9242468) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: 31586954) AND COULD NOT ADVANCE ANY MORE. THEY ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF Y CONNECTOR. THE DOCTOR SWITCHED A SECOND NEW STENT, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452812, LOT NUMBER: 9616877), BUT THIS SECOND STENT WAS ALSO IMPEDED IN THE MIDDLE SECTION OF THE ORIGINAL MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE SECOND STENT, THE SECOND STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE ORIGINAL MICROCATHETER. THE DOCTOR REMOVED THE SECOND STENT AND THE ORIGINAL MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO A SECOND NEW MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (PRODUCT CODE: 606S255X, LOT NUMBER: 31626342). A THIRD STENT, A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9924736) ALSO IMPEDED IN THE MIDDLE SECTION OF THE SECOND MICROCATHETER. THE DOCTOR REMOVED THE SECOND MICROCATHETER AND THE THIRD STENT FROM THE PATIENT AND SWITCHED OUT TO NEW DEVICES (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR ADVERSE IMPACT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED. THE COMPLAINT DEVICES ARE AVAILABLE FOR RETURN AND FURTHER ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-DEC-2025 INDICATED THAT THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THERE WERE NO VESSELS OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2846009 PROWLER SELECT CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDOS INTERNATIONAL SARL 31586954 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EU ENT4.5MMD 28MML WNO DSTL TP.