BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC MERLIN PTCA CATHETER (OTW)

    MDR report key: 2010720 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01515
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P910031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED BALLOON CATHETER NOTED CONTRAST VISIBLE IN THE HUB AND IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION OF THE DEVICE FOR USE. THE BALLOON WAS STILL TIGHTLY FOLDED. THE INFLATION PORT OF THE HUB WAS RETURNED SEPARATED AT THE BASE OF THE INFLATION PORT, CONFIRMING THE REPORTED COMPLAINT. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. FACTORS THAT CAN CONTRIBUTE TO A SIDE ARM SEPARATION INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE DURING MANUFACTURING, OVER-TORQUING THE SIDEARM WITH THE INFLATION DEVICE OR A SYRINGE, MATERIAL DEFICIENCIES, HANDLING DURING SHIPMENT TO THE ACCOUNT, HANDLING AT THE ACCOUNT, OR DAMAGE DURING PACKAGING/SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. IN THIS CASE, IT IS POSSIBLE THAT THE SIDE ARM WAS OVER-TORQUED WITH THE SYRINGE DURING PREPARATION FOR USE, SUCH THAT IT CRACKED AND SEPARATED AS A RESULT, ALTHOUGH THIS CANNOT BE CONFIRMED. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, A SAMPLING OF ALL LUERS IS DESTRUCTIVELY TESTED FOR ENVIRONMENT STRESS CRACKING TO VERIFY LUER INTEGRITY. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE ANALYSIS OF THE RETURNED PRODUCT, A DEFINITIVE CAUSE FOR THE REPORTED SEPARATION CANNOT BE DETERMINED, HOWEVER, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A QUALITY DEFICIENCY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION WHEN NEGATIVE PRESSURE WAS PULLED USING A SYRINGE, THE PROXIMAL END OF THE HUB CRACKED AND SEPARATED. THE DEVICE WAS NOT USED IN THE PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC MERLIN PTCA CATHETER (OTW) CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 648415

    Patients

    Seq Age Sex Outcome Treatment
    1