BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS 150/5CM

    MDR report key: 15184729 · Received August 8, 2022

    Report

    Report Number
    3008114965-2022-00525
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    May 12, 2022
    Report Date
    August 8, 2022
    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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 3008114965-2022-00388. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, A 4.5X37MM ENTERPRISE STENT 12 MM DW TIP (ENC453712, 6920548) BECAME IMPEDED IN A 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255X, 30686635) AND RELEASED OUTSIDE OF THE PATIENT¿S BODY. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT ARRIVED IN THE PARENT ARTERY AND RELEASED THE DISTAL END OF THE STENT FOR ABOUT 5MM. THE PHYSICIAN OBSERVED THAT THE POSITION OF THE STENT WAS NOT APPROPRIATE, THEN HE TRIED TO RETRACT IT FOR ADJUSTING, BUT FELT SOME RESISTANCE. THE STENT WAS RETRACTED INTO THE MICROCATHETER AFTER SEVERAL ATTEMPTS. THE DOCTOR TRIED TO RELEASE THE STENT AGAIN, BUT STILL FELT RESISTANCE. THE STENT COULD NOT BE RELEASED COMPLETELY (COULD ONLY RELEASE THE DISTAL END OF THE STENT FOR ABOUT 2MM). THE STENT WAS WITHDRAWN AND FOUND TO BE RELEASED ON THE OPERATION TABLE. A NEW STENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE DEVICE FROM THE PATIENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE SYSTEM WAS USED WITH THE RECOMMENDED MICROCATHETER. THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. IT WAS NECESSARY TO REMOVE THE MC WITH THE ENTERPRISE. THE TARGET SITE BEING TREATED WAS THE LEFT MIDDLE CEREBRAL ARTERY. IT WAS NOTED THAT THE VESSEL WAS CURVED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PRODUCT WAS RETURNED TO CERENOVUS FOR EVALUATION. A NON-STERILE PROWLER SELECT PLUS 150/5CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND A SLIGHT KINK WAS NOTED AT 78CM (30.7 INCHES) FROM THE PROXIMAL END. A DIMENSIONAL TEST WAS PERFORMED FOR THE DEVICE, DEVICE OD (OUTER DIAMETER) HUB ID (INNER DIAMETER), AND THE DISTAL ID (INNER DIAMETER) WERE CONFIRMED TO BE WITHIN SPECIFICATION. THE DEVICE WAS FLUSHED USING A LAB SAMPLE SYRINGE. AFTER THAT, A GUIDE WIRE .018 INCH LAB SAMPLE WAS INTRODUCED INTO THE DEVICE AND IT COULD NOT ADVANCE FURTHER THAN WHERE THE KINK IS LOCATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CUSTOMER COMPLAINT WAS CONFIRMED DUE TO THE FINDING OBSERVED. IS POSSIBLE THAT THE KINK OBSERVED IS A RESULT OF THE MANEUVERING OF THE DEVICE DURING THE EVENT. HOWEVER, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES WERE IDENTIFIED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURES AND DAMAGES ON THE RETURNED SYSTEM. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, A 4.5X37MM ENTERPRISE STENT 12 MM DW TIP (ENC453712, 6920548) BECAME IMPEDED IN A 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255X, 30686635) AND RELEASED OUTSIDE OF THE PATIENT¿S BODY. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT ARRIVED IN THE PARENT ARTERY AND RELEASED THE DISTAL END OF THE STENT FOR ABOUT 5MM. THE PHYSICIAN OBSERVED THAT THE POSITION OF THE STENT WAS NOT APPROPRIATE, THEN HE TRIED TO RETRACT IT FOR ADJUSTING, BUT FELT SOME RESISTANCE. THE STENT WAS RETRACTED INTO THE MICROCATHETER AFTER SEVERAL ATTEMPTS. THE DOCTOR TRIED TO RELEASE THE STENT AGAIN, BUT STILL FELT RESISTANCE. THE STENT COULD NOT BE RELEASED COMPLETELY (COULD ONLY RELEASE THE DISTAL END OF THE STENT FOR ABOUT 2MM). THE STENT WAS WITHDRAWN AND FOUND TO BE RELEASED ON THE OPERATION TABLE. A NEW STENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE DEVICE FROM THE PATIENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE SYSTEM WAS USED WITH THE RECOMMENDED MICROCATHETER. THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. IT WAS NECESSARY TO REMOVE THE MC WITH THE ENTERPRISE. THE TARGET SITE BEING TREATED WAS THE LEFT MIDDLE CEREBRAL ARTERY. IT WAS NOTED THAT THE VESSEL WAS CURVED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026945 PROWLER SELECT PLUS 150/5CM CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 606-S255X 30686635 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EU 4.5X37MM STENT 12 MM DW TIP