BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 8588202 · Received May 7, 2019

    Report

    Report Number
    1820334-2019-01028
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    February 15, 2019
    Report Date
    May 7, 2019
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    10827002522708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME = DQY. PRODUCT CODE = DQY. (B)(6). PMA/510(K) NUMBER = K091527. INVESTIGATION ¿ EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER TO COOK FOR INVESTIGATION. THE BALLOON WAS SEVERED. ELONGATION AND BUNCHING WERE NOTED ALONG THE LENGTH OF THE SHAFT. NO DAMAGE WAS NOTED TO THE BALLOON SURFACE, AND THE MARKER BANDS WERE BOTH PRESENT. INVESTIGATION WAS ABLE TO SUCCESSFULLY RECREATE THE REPORTED FAILURE MODE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THREE NONCONFORMING EVENTS WHICH COULD POTENTIALLY CONTRIBUTE TO THIS FAILURE MODE. THESE NONCONFORMANCES WERE FOR A MICRO TEAR TO THE RIGHT OF THE PROXIMAL MARKER BAND, SHAFT DAMAGE, AND A SHORT TIP. THOUGH THESE NONCONFORMANCES WERE RELATED TO THE REPORTED FAILURE, THE AFFECTED UNITS WERE SCRAPPED AND NOT REPLACED. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE DRAWINGS, QUALITY CONTROL PROCEDURES, AND OVERALL DESIGN HISTORY FILE WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE, WHICH STATES ¿IF RESISTANCE IS MET WHILE ADVANCING THE DEVICE, DETERMINE THE CAUSE AND PROCEED WITH CAUTION." BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT A ROOT CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION OR, WHEN ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 17FEB2019, A PHYSICIAN HAD A "SITUATION" WITH AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WHICH BECAME LODGED IN A FIFTY-FIVE CM, FIVE FR SHEATH (COOK). THE PHYSICIAN CUT THE SHEATH AFTER IT WAS WITHDRAWN FROM THE PATIENT. THE BALLOON WAS STUCK NEAR THE VALVE. ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING DETAILS OF THIS EVENT. A RESPONSE WAS RECEIVED 25APR2019 FROM THE PHYSICIAN, WHO PROVIDED THE FOLLOWING INFORMATION: "I USED A LONG 5FR SHEATH IN AN UP AND OVER FASHION TO THE CONTRALATERAL LEG. I USED A BALLOON TO PERFORM MULTIPLE ANGIOPLASTIES. UPON RETRIEVING THE BALLOON, IT BECAME STUCK IN THE SHEATH. I TRIED PULLING THE BALLOON WITH NEGATIVE PRESSURE WITHOUT SUCCESS. I TRIED REPEATEDLY TO REMOVE THE BALLOON UNTIL THE BALLOON RIPPED AND BECAME STUCK IN THE SHEATH. I EVENTUALLY NEEDED TO PULL THE SHEATH WITH THE BALLOON REMNANT AND WIRE AND LOST ACCESS BEFORE THE CASE WAS COMPLETE. I THEN CUT THE SHEATH AND FOUND THAT THE BALLOON WAS STUCK AT THE MEMBRANE AT THE SHEATH ENTRY SITE." NO PATIENT ADVERSE EFFECT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378304 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY COOK INC G52270 9025754 10827002522708

    Patients

    Seq Age Sex Outcome Treatment
    1