BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2123644 · Received June 14, 2011

    Report

    Report Number
    2024168-2011-04174
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A BEND IN THE HYPOTUBE 3.5 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BEND MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER, WHEN WATER LEAKED OUT OF A LONGITUDINAL RUPTURE WITH A FLAP, 1 MM IN LENGTH, 3 MM DISTAL TO THE PROXIMAL BALLOON SHOULDER. THERE WERE SEVERAL FLAPS IN THE FULL LENGTH OF THE BALLOON. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH THE STENT OR OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE LEAK TESTED ON LINE AND A SAMPLING OF UNITS ARE RUPTURE TESTED PRIOR TO RELEASE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO USE. ANALYSIS NOTED SEVERAL FLAPS OF TORN BALLOON MATERIAL. DAMAGE OF THIS TYPE CAN BE THE RESULT OF MATERIAL PROCESSING OR INCORRECT PREPARATION FOR USE. IT WAS REPORTED THAT THE DEVICE WAS INCORRECTLY PREPARED FOR USE BY THE TECHNICIAN. THE RX TREK INSTRUCTIONS FOR USE STATES TO SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. ALL AIR MUST BE REMOVED FROM THE BALLOON AND DISPLACED WITH CONTRAST PRIOR TO INSERTING INTO THE BODY; OTHERWISE, COMPLICATIONS MAY OCCUR. IT IS LIKELY THAT THE HYDROPHILIC COATING ON THE BALLOON WAS NOT ACTIVATED UPON EXPOSURE TO MOISTURE SUCH THAT AS THE BALLOON WAS INFLATED, THE BALLOON MATERIAL TORE AND PEELED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    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

    IT WAS REPORTED THAT DURING PREPARATION OF THE RX TREK DILATATION CATHETER, THE TECHNICIAN (IN TRAINING) INFLATED THE BALLOON. A PINHOLE WAS NOTED AND CONTRAST WAS LEAKING. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND ANOTHER SAME DEVICE WAS USED SUCCESSFULLY TO PERFORM DILATATION. CATH LAB STAFF REPORTED THAT THE TECHNICIAN DID NOT PREP THE DEVICE CORRECTLY (INFLATED THE BALLOON). THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1040461

    Patients

    Seq Age Sex Outcome Treatment
    1