BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 9539150 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00032
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 12, 2019
    Report Date
    June 29, 2020
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002503394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN ANGIOGRAM OF THE LOWER LEG, "PLASTIC STRANDS" CAME OFF OF AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BALLOON AS IT WAS WIPED DOWN. THE STRANDS WERE APPROXIMATELY ONE INCH IN LENGTH. THE DEVICE DID NOT MAKE PATIENT CONTACT. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE USER RETURNED ONE PRIOR TO USE PTAX4-14-170-4-16 FOR INVESTIGATION. THE BALLOON WAS INFLATED. STRANDS OF HYDROPHILIC COATING WERE VISIBLE COMING OFF THE BALLOON SURFACE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. NO GAPS WERE DISCOVERED IN THE MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, DRAWING, OR QUALITY CONTROL PROCEDURES FOR THIS DEVICE. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT IS PACKAGED WITH INSTRUCTIONS FOR USE, WHICH STATE, ¿UPON REMOVAL FROM PACKAGE, INSPECT CATHETER TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING,¿ AND, ¿ACTIVATE THE HYDROPHILIC COATING BY WIPING THE BALLOON WITH HEPARINIZED SALINE SOLUTION.¿ BASED ON THE INFORMATION AVAILABLE, INVESTIGATION HAS CONCLUDED THAT A CAUSE COULD NOT BE ESTABLISHED FOR THIS EVENT. 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 IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION = UNKNOWN. PMA/510(K) NUMBER= K170193. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN ANGIOGRAM OF THE LOWER LEG, "PLASTIC STRANDS" CAME OFF OF AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BALLOON AS IT WAS WIPED DOWN. THE STRANDS WERE APPROXIMATELY ONE INCH IN LENGTH. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344 ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC G50339 9903180 10827002503394

    Patients

    Seq Age Sex Outcome Treatment
    1