BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 4240555 · Received November 10, 2014

    Report

    Report Number
    2024168-2014-07302
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INCIDENT INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS/COMPLAINT HISTORY, AND THE ANALYSIS OF THE RETURNED STEERABLE GUIDING CATHETER (SGC) WERE REVIEWED. EXAMINATION OF THE DILATOR CONFIRMED THE PRESENCE OF STRANDS OF FIBERS ON THE OUTER DIAMETER OF THE DILATOR, BETWEEN THE DILATOR TIP AND THE SGC SOFT TIP. THE FIBERS WERE SUBMITTED FOR CHEMICAL ANALYSIS AND WERE DETERMINED TO BE RAYON FIBERS. POTENTIAL CAUSES FOR FOREIGN MATERIAL ON THE DEVICE CAN INCLUDE, BUT ARE NOT LIMITED TO, USER TECHNIQUE / PROCEDURAL CONDITIONS (INTERACTION BETWEEN THE DILATOR AND SURGICAL CLOTHING) OR MANUFACTURING ANOMALIES. WITH RESPECT TO USER TECHNIQUE / PROCEDURAL CONDITIONS, FOREIGN MATERIAL ON THE DEVICE MAY BE INFLUENCED BY HANDLING OF THE DILATOR PRIOR TO USE. THIS INCIDENT WAS FURTHER REVIEWED BY AN ABBOTT VASCULAR SENIOR MEDICAL ADVISOR, WHO CONCLUDED THAT THE IDENTIFIED RAYON MATERIAL CAN BE FOUND ON SURGICAL SCRUBS WHICH ARE WORN UNDERNEATH THE GOWNS. IN THIS CASE, IT IS POSSIBLE THAT DURING PREPARATION OF THE DILATOR, THE DILATOR TIP MAY HAVE COME INTO CONTACT WITH SURGICAL SCRUB MATERIAL, RESULTING IN THE TRANSFERENCE OF FIBERS TO THE DILATOR; HOWEVER, A DEFINITIVE CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED AND THE EVALUATION OF THE RETURNED FIBERS, A DEFINITIVE CAUSE FOR THE FOREIGN MATERIAL ON THE DEVICE COULD NOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT-HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS FOR THE REPORTED LOT FOR THE REPORTED FOREIGN MATERIAL PRESENT ON DEVICE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT THE FOREIGN MATERIAL NOTED ON THE DILATOR DURING PREPARATION. ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT, IF A FOREIGN BODY WERE TO ENTER THE ANATOMY THERE'S POTENTIAL OF INJURY. IT WAS REPORTED THAT THE STEERABLE GUIDING CATHETER (SGC) WAS REMOVED FROM THE PACKAGING AND THE DEVICE BEGAN TO BE PREPARED FOR USE, PER THE INSTRUCTIONS FOR USE (IFU). WHEN THE GUIDE TIP WAS ABOUT TO BE SUBMERGED IN SALINE, IT WAS OBSERVED THAT THERE WERE BLACK STRANDS ON THE SURFACE OF THE DILATOR, DISTAL TO THE GUIDE TIP. THE STRANDS WERE SOME TYPE OF FIBER ABOUT 1 CENTIMETER LONG (MORE THAN 1). THE FIBERS WERE OBSERVED AFTER THE DILATOR HAD BEEN INSERTED INTO THE GUIDE AND FUNCTIONAL INSPECTION HAD BEEN PERFORMED BUT BEFORE THE DILATOR WAS RETRACTED TO CREATE A SMOOTH TRANSITION. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SGC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE INTENDED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723924 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 10338545

    Patients

    Seq Age Sex Outcome Treatment
    1