BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROWLER SELECT

    MDR report key: 21218016 · Received January 23, 2025

    Report

    Report Number
    3008114965-2025-00080
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 3, 2025
    Report Date
    April 3, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRA
    UDI-DI
    10886704028888
    PMA / PMN Number
    K021591
    Adverse Event
    Yes
    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). 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. THE COMPLAINT WAS SUBMITTED WITH PROCEDURAL IMAGES, WHICH ARE PENDING FURTHER ANALYSIS. CATHETER OBSTRUCTION WHILE-IN PATIENT WITH LOSS OF CEREBRAL TARGET POSITION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE PROWLER SELECT PLUS MICROCATHETER. LOSS OF MICROCATHETER TARGET POSITION IN THE INTRACRANIAL VASCULATURE (WITH THE EXCEPTION OF THE INTERNAL CAROTID ARTERY) WILL REQUIRE RE-ACCESSING THE TARGET SITE WITH INCREASED POTENTIAL FOR VESSEL TRAUMA, VESSEL SPASM, AND/OR ISCHEMIA/INFARCT. THERE ARE CLINICAL AND PROCEDURAL FACTORS INCLUDING CLOT BURDEN, VESSEL CHARACTERISTICS (I.E., TORTUOSITY), AND MECHANICAL MANIPULATION OF DEVICES THAT MAY HAVE CONTRIBUTED TO THIS EVENT RATHER THAN A DEVICE DESIGN OR MANUFACTURING ISSUE. IN THIS CASE, THERE WERE NO REPORTS OF PATIENT INJURY; HOWEVER, THE EVENT RESULTED IN A TWO-HOUR SURGICAL DELAY. THE SEVERITY IS UNKNOWN. AS EXPLAINED IN THE REFERENCED MEDICAL LITERATURE, INCREASED ANESTHESIA TIME COULD RESULT IN INCREASED IMMUNOLOGICAL SUPPRESSION, FORMATION OF CLOTS, AND RATE OF VENOUS THROMBOEMBOLISMS. BASED ON THIS INFORMATION, THIS EVENT WILL BE CONSERVATIVELY REPORTED TO THE US FDA UNDER REPORTING CRITERIA 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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. 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). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3, H6 AND H11. TWO VIDEO CLIPS WERE RECEIVED AND REVIEWED BY (B)(4) MEDICAL AFFAIRS DIRECTOR, THE RESULTS ARE SHOWN BELOW: ¿THE DETAILED DESCRIPTION IS ACCOMPANIED BY TWO VIDEO CLIPS, WITH A ROADMAP VIEW, THAT CLEARLY SHOWS THE DIFFICULTY IN POSITIONING/RETRIEVING THE STENT. THE CAUSE OF THIS IS NOT CLEAR FROM THE IMAGES AND THE DEVICES SHOULD BE INVESTIGATED UPON RETURN IF A ROOT CAUSE NEEDS TO BE DETERMINED. IN THIS CASE IT IS NOT EVEN CLEAR WHETHER THE STENT OR THE MICROCATHETER CAUSED THE PROBLEM, ALTHOUGH THERE CLEARLY IS AN INTERACTION HAPPENING¿. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31411529 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H3, H6 AND H11. 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 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31411529 NUMBER, AND NO NON-CONFORMANCES 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX23MM (ENCR402312/ 9020421), A PROWLER SELECT PLUS 150/5CM (606S255X /31395321), AND A PROWLER SELECT PLUS 150/5CM (606S255X/ 31411529), WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED STENT- WITHDRAWAL DIFFICULTY (UNABLE TO) AND MICROCATHETER(S) OBSTRUCTION -IN PATIENT WITH LOSS OF CEREBRAL TARGET POSITION. THE EVENT WAS REPORTED AS SUCH, ¿IMPEDED IN MICROCATHETER. IT WAS REPORTED THAT PATIENT WAS SUFFERED FROM C6 SEGMENT ANEURYSM OF INTERNAL CAROTID ARTERY, AND THE ANEURYSM SIZE WAS 3MM. DURING PROCESS OF SEMI-RELEASE STENT ASSISTED COIL EMBOLIZATION OF THE ANEURYSM, THE COIL MICROCATHETER (OTHER BRAND) MIGRATED OUTSIDE THE ANEURYSM. THE DOCTOR ATTEMPTED TO RETRACT THE STENT FOR ADJUSTING, BUT THE STENT WAS IMPEDED IN THE STENT MICROCATHETER AND COULD NOT BE RETRACTED, THEN REMOVED THE STENT AND STENT MICROCATHETER FROM PATIENT. PHYSICIAN REPLACED THE STENT AND STENT MICROCATHETER WITH NEW ONES TO ADJUST THE COIL MICROCATHETER POSITION AGAIN, BUT STILL FAILED, THEN TRIED TO WITHDRAW THE STENT. IT WAS FOUND THAT THE SECOND STENT WAS IMPEDED IN THE SECOND STENT MICROCATHETER AND COULD NOT BE WITHDRAWN. THE DOCTOR REMOVED THE SECOND STENT AND STENT MICROCATHETER, THEN SWITCHED THE THIRD STENT MICROCATHETER TO COMPLETE THE SURGERY WITH THE SECOND STENT. THE PROCEDURE WAS PROLONGED ABOUT 2 HOURS.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 10-JAN-2025. SUMMARY: PER THE EVENT DESCRIPTION, ¿THE PHYSICIAN REPLACED THE STENT AND STENT MICROCATHETER WITH NEW ONES TO ADJUST THE COIL MICROCATHETER POSITION AGAIN, BUT STILL FAILED, THEN TRIED TO WITHDRAW THE STENT. IT WAS FOUND THAT THE SECOND STENT WAS IMPEDED IN THE SECOND STENT MICROCATHETER AND COULD NOT BE WITHDRAWN.¿ THE SECOND STENT USED WAS AN ENTERPRISE2 4MMX23MM (ENCR402312/ 8697544); (B)(4). THE DELIVERY WIRE DID NOT SNAG OR GET CAUGHT ON THE STENT. POSSIBLE CAUSES FOR THE EVENT OR FACTORS CONTRIBUTING TO THE EVENT WERE UNKNOWN. THE DEVICES WERE EASILY REMOVED FROM THE PATIENT WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. IT IS UNKNOWN IF THE STENT REMAINED PATENT WITHOUT DAMAGE. THE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. RELEVANT ANATOMICAL INFORMATION WAS NOTED AS, ¿THE VESSEL WAS SEVERELY TORTUOUS, THE SIZE OF THE ANEURYSM WAS 3 MM, AND THE ANEURYSM WAS LOCATED ON THE LATERAL WALL OF THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY.¿ PATIENT DEMOGRAPHICS AND MEDICAL HISTORY WERE UNOBTAINABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS. NO FURTHER INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439881 PROWLER SELECT CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 31411529 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H ENTERPRISE2 4MMX23MM.