BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 14 NEURO GUIDEWIRE

    MDR report key: 886115 · Received September 14, 2006

    Report

    Report Number
    6000078-2005-00276
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Report Date
    April 16, 2005
    Manufacturer
    NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K) #: K023700, K002907. THE PRODUCT WAS RETURNED WITH MOST OF ITS ORIGINAL PACKAGING CONTENTS (POUCH AND CARTON), THE GUIDE WIRE WAS CONTAINED WITHIN THE POUCH. THE WIRE WAS REMOVED FROM THE POUCH AND VISUALLY EXAMINED, SLIGHT KINKING WAS OBSERVED IN THE PROXIMAL PTFE COATED END OF THE WIRE WITH SOME OF THE PTFE COATING MISSING THROUGHOUT THE PTFE COATED SECTION. THE KINK WAS OBSERVED APPROX 10CM INFERIOR TO THE PROXIMAL END OF THE GUIDEWIRE. THE TORQUE DEVICE WAS NOT RETURNED WITH THE PRODUCT. ALSO RETURNED WAS A CATHETER, HEMOSTASIS VALVE, AND STOPCOCK, EACH OF THESE DEVICES WERE VISUALLY EXAMINED FOR EVIDENCE OF PEELED COATING WHICH, WAS NOT OBSERVED. EACH OF THESE DEVICES WHERE FLUSHED WITH CAVICIDE DURING DECONTAMINATION AND THE FLUIDS THAT WHERE EXPELLED FROM THE LUMENS OF EACH OF THESE DEVICES WERE COLLECTED IN CLEAR SPECIMEN DISHES SO THAT THE FLUIDS COULD BE CLOSELY EXAMINED FOR ANY SIGNS OF PEELED COATING THAT MAY HAVE REMAINED IN THE LUMENS OF THESE DEVICES. THERE WERE NO VISIBLE SIGNS OF PEELED COATING FLUSHED FROM THE LUMENS OF THESE DEVICES OR ANY OTHER VISIBLE FOREIGN MATTER. THE GUIDEWIRE AND DEVICES WERE DECONTAMINATED BY SOAKING IN CAVICIDE FOR 15 MINUTES. A VISUAL EXAMINATION OF THE PTFE COATING IN THE PROXIMAL END WAS OBSERVED UNDER 40X MAGNIFICATION, REVEALING THE PTFE COATING DAMAGE IS LOCATED ALL THROUGHOUT THE PTFE COATED SECTION IN DIFFERENT REGIONS RANGING BETWEEN 21CM PROXIMAL OF THE PTFE COATED TERMINATION AND EXTENDING TO THE PROXIMAL END OF THE GUIDEWIRE. THERE ARE APPROX A DOZEN LOCATIONS LOCATED THROUGHOUT THE PTFE COATED SECTION THAT ARE MISSING SEGMENTS OF COATING (SEGMENTS WITH MISSING PTFE COATING RANGE FROM 0.5CM TO 5CM). CLEAR INDICATIONS WERE GIVEN THAT THE PTFE COATING HAD BEEN PARTIALLY PEELED DUE TO SHEERING FORCES WITH THE PARTIAL PIECES OF PTFE COATING STILL ATTACHED. THE SHEERING/PEELING OF THE PTFE COATING IS ERRATIC THROUGHOUT THE PTFE COATED SECTION OF THE WIRE, IN SOME AREAS, THE COATING IS INTACT AND IN MOST AREAS WHERE THE COATING IS MISSING, IT IS MISSING FROM 360B AROUND THE WIRE. ALSO OBSERVED AT THE DAMAGED LOCATION WERE IMPRESSIONS/MARKS OR SCRATCHING IN THE SS WIRE AND COATING STILL REMAINING ON THE WIRE WHICH INDICATES THAT SOMETHING WAS DRAGGED ALONG THE LENGTH OF THE WIRE AND AGAIN CONFIRMING THAT SHEERING FORCES WHERE APPLIED. SUCH A FAILURE CAN OCCUR WHEN THE TORQUE DEVICE HAS NOT BEEN PROPERLY SECURED TO THE WIRE. SIMULATED USE STUDIES HAVE PREVIOUSLY BEEN PERFORMED IN THE LAB TO EVALUATE THE EFFECTS OF THE TORQUE DEVICE ON PTFE COATING. THE FIRST SIMULATED TEST PERFORMED HAD THE TORQUE DEVICES PROPERLY SECURED. THE RESULTS WERE AS FOLLOWS. A GUIDE WIRE WAS USED TO CONDUCT THIS TEST BY CUTTING THE PROXIMAL PTFE COATED SECTION INTO THREE (3) SEGMENTS. A TORQUE DEVICE WAS ATTACHED TIGHTLY/SECURELY TO ONE END OF EACH WIRE, WHILE ANOTHER TORQUE DEVICE WAS ATTACHED TO THE OPPOSITE END, EACH WITH A DIFFERENT AMOUNT OF TORQUE APPLIED TO SECURE IT IN PLACE. THE FIRST EVALUATION WAS MADE TO THE TORQUE DEVICE THAT WAS TIGHTLY SECURED IN THE PTFE COATED WIRE, WHICH WAS THEN TURNED FOR TORQUE. THE OPPOSITE TORQUE DEVICE WAS SECURELY HELD INTO PLACE TO ADD RESISTANCE. THE EVALUATION CONCLUDED THAT WHEN BOTH TORQUE DEVICES ARE SECURELY CLAMPED TO THE WIRE, THAT TWISTING OCCURS IN THE WIRE, BUT NO MOVEMENT OCCURS IN THE TORQUE DEVICES. THE TORQUE DEVICE WAS THEN REMOVED AND THE PTFE COATING WAS OBSERVED UNDER MAGNIFICATION. THE ONLY DAMAGE OBSERVED WERE IMPRESSIONS OF THE BRASS COLLETT LEFT IN THE PTFE COATING, WHILE NO PEELING OF THE COATING WAS OBSERVED. THE SAME EVALUATION WAS CONDUCTED AGAIN, BUT THIS TIME THE TORQUE DEVICE CLAMPED TO THE OPPOSITE END OF THE TIGHTLY SECURED TORQUE DEVICE, IT BEING ONLY LIGHTLY CLAMPED TO THE PTFE COATED WIRE. WHEN TORQUE WAS APPLIED SLIPPING OCCURRED IN THE LIGHTLY CLAMPED TORQUE DEVICE. THE WIRE WAS THEN OBSERVED UNDER MAGNIFICATION WHICH PEELED AND SHEERED THE PTFE COATING FROM THE FULL RADIUS OF THE WIRE. THE SAME EVALUATION WAS AGAIN PERFORMED FOR A THIRD TIME, YET THIS TIME THE TORQUE DEVICE WAS SECURED TO THE WIRE IN A SEGMENT BETWEEN THE RANGE OF THE FIRST EVALUATION (TIGHTLY SECURED) AND THE SECOND EVALUATION (LIGHTLY SECURED). THE MEDIUM SECURED TORQUE DEVICE SLIPPED WHEN A FORCE WAS APPLIED TO THE TIGHTLY SECURED WIRE AT THE OPPOSITE END, WHICH AGAIN WAS HELD TO ADD RESISTANCE. THE RESULTS OF THE TEST WERE AGAIN EVALUATED UNDER MAGNIFICATION AND AGAIN, THE APPEARANCE OF THE COATING WAS INDICATIVE OF A SHEERING FORCE, BUT THIS TIME THE COATING WAS ONLY PARTIALLY PEELED. THE TORQUE DEVICE WAS NOT RETURNED WITH THE GUIDE WIRE; HOWEVER, THE SIMULATED LAB STUDY INDICATES THIS TYPE OF FAILURE CAN OCCUR FROM NOT PROPERLY SECURING THE TORQUE DEVICE TO THE WIRE. BECAUSE OF THE KINKING THAT WAS ALSO OBSERVED IN THIS AREA, IT WOULD SUGGEST THAT EITHER THE TORQUE DEVICE WAS USED IN AN OVERLY AGGRESSIVE MANNER OR THAT SOME OTHER TYPE OF INSTRUMENT WAS USED ON THE WIRE IN THIS REGION FOR UNKNOWN PURPOSES. THE DISTAL MICROMACHINED NITINOL SECTION WAS ALSO OBSERVED UNDER 40X MAGNIFICATION WHICH REVEALED NO SIGNS OF PEELED COATING OR OTHER UNUSUAL DEFECTS. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO FINDINGS WHICH RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: AN ANONYMOUS SOURCE, REPORTED TO BE A PHYSICIAN NOTIFIED BOSTON SCIENTIFIC THAT THEY OBSERVED FLAKING OF THE GUIDEWIRE COATING. NO FURTHER INFO WAS PROVIDED TO BOSTON SCIENTIFIC REGARDING THE PROCEDURE OR PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 14 NEURO GUIDEWIRE GUIDEWIRE DQX NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP 1301 B04474

    Patients

    Seq Age Sex Outcome Treatment
    1 *