BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 7569365 · Received June 5, 2018

    Report

    Report Number
    1820334-2018-01601
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 26, 2018
    Manufacturer
    COOK INC
    Product Code
    DQY
    PMA / PMN Number
    K073378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: THE CUSTOMER CONFIRMED THAT, DURING AN "ANGIO" [SIC] OF THE SUPERFICIAL FEMORAL ARTERY, AFTER ACCESS WAS OBTAINED AND THE BALLOON WAS ADVANCED TO THE SITE OF INFLATION, THE INFLATED BALLOON RUPTURED LONGITUDINALLY AT A PRESSURE OF 12 ATMOSPHERES (ATM). THE CUSTOMER CONFIRMED THAT THE VESSEL WAS NEITHER TORTUOUS NOR PARTICULARLY CALCIFIED, ALTHOUGH THE CALCIFICATION WAS CHARACTERIZED AS MINIMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BALLOON DEVICE. VISIPAQUE CONTRAST WAS EMPLOYED WITH SALINE, WITH A 40/60 RATIO EMPLOYED. THERE WAS NO ANGULATION. D11 CONCOMITANT MEDICAL PRODUCTS: V18 WIRE (BOSTON SCIENTIFIC), ENCORE INFLATION HANDLE (BOSTON SCIENTIFIC), 5 FRENCH SHEATH (TERUMO). INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH NOTES: THE BALLOON IS MANUFACTURED FROM AN EXTRA-THINWALL, HIGH-STRENGTH, MINIMALLY-COMPLIANT MATERIAL. PARTICULAR CARE SHOULD BE TAKEN IN HANDLING THE BALLOON TO PREVENT DAMAGE. WARNINGS: DO NOT EXCEED RATED BURST PRESSURE. RUPTURE OF BALLOON MAY OCCUR. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS IN THE COMPLIANCE CARD INSERT. OVER-INFLATION MAY CAUSE RUPTURE OF THE BALLOON, WITH RESULTANT DAMAGE TO THE VESSEL WALL. USE OF A PRESSURE GAUGE IS RECOMMENDED TO MONITOR INFLATION PRESSURES. INSTRUCTIONS FOR USE: CHOOSE A BALLOON APPROPRIATE TO LESION LENGTH AND VESSEL DIAMETER. UPON REMOVAL FROM PACKAGE, INSPECT THE CATHETER TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING. HOW SUPPLIED: STORE IN A DARK, DRY COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THE AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED (REFER TO MEDWATCH: 1820334-2018-01545). ADDITIONALLY, THE PHYSICIAN REPORTED THREE OTHER OCCURRENCES WHERE ADVANCE 18 LP LOW PROFILE BALLOON CATHETERS (LOTS UNKNOWN), HAVE RUPTURED (REFER TO THIS REPORT). NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412249 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1