BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2061681 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02722
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE SHAFT AND IN THE INFLATION LUMEN AND THE BALLOON WAS ALSO LOOSELY-FOLDED. THIS IS CONSISTENT WITH HANDLING, THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE. THE ANALYSIS CONFIRMED THAT THERE WAS A LONGITUDINAL RUPTURE IN THE BALLOON IN THE DISTAL TAPER, EXTENDING PROXIMALLY FOR A LENGTH OF 4.5 CM. AS A RESULT OF THE PINHOLE, THE BALLOON COULD NOT BE FULLY DEFLATED TO MEASURE THE 2/3 BALLOON PROFILE. PHYSICAL RESISTANCE DURING ADVANCEMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE CATHETER, AND INTERACTIONS WITH OTHER DEVICES OR ACCESSORY DEVICE SUPPORT. IN THIS CASE, THE LESION WAS REPORTED AS MILDLY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. FURTHERMORE, BALLOON MATERIAL RUPTURES MAY RESULT FROM FACTORS SUCH AS, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. SINCE THERE WAS NO REPORT OF ANY DAMAGE OR LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE CATHETER WAS ULTIMATELY SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS, WHICH CONFIRMED THAT THE RUPTURE INITIATED FROM THE INNER SURFACE OF THE BALLOON. THIS TYPE OF RUPTURE IS MOST CONSISTENT WITH EXPOSURE CONDITIONS DURING THE PROCEDURE, A MATERIAL/PROCESSING DISCREPANCY, MULTIPLE INFLATIONS AND/OR HIGH STRESS BEING APPLIED TO THE BALLOON MATERIAL. THERE WAS ALSO SLIGHT MECHANICAL DAMAGE NOTED ON THE BALLOON; HOWEVER, THIS WAS NOT LOCATED AT OR NEAR THE FAILURE AND MAY HAVE BEEN A RESULT OF INTERACTIONS WITH OTHER DEVICES AND/OR THE CALCIFIED LESION AS SLIGHT WAS RESISTANCE WAS ENCOUNTERED. REPORTEDLY, THE BALLOON WAS NOT SOAKED IN SALINE DURING DEVICE PREPARATION. IT SHOULD BE NOTED THAT THE PRODUCT IFU STATES: SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IF THE BALLOON IS NOT SUBMERGED IN SALINE DURING BALLOON PREPARATION TO ACTIVATE THE HYDROPHILIC COATING, THIS CAN CONTRIBUTE TO A BALLOON RUPTURES. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL PRODUCT DEFICIENCY, THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, ALL PRODUCTS ARE LEAK TESTED ONLINE AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE (RBP) AND BALLOON INTEGRITY. THERE WAS ALSO A BEND NOTED IN THE HYPOTUBE, 4 CM DISTAL TO THE STRAIN RELIEF TUBING. HOWEVER, THIS DAMAGE WAS NOT ORIGINALLY REPORTED AND LIKELY OCCURRED FROM FURTHER HANDLING AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE ANALYSIS OF THE RETURNED PRODUCT AND THE RESULTS OF THE SEM ANALYSIS, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO OPERATION CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR A BALLOON RUPTURE FROM THIS LOT. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OBTUSE MARGINAL WITH MILD CALCIFICATION. THE RX TREK WAS ADVANCED; HOWEVER, THE BALLOON RUPTURED WHEN INFLATED TO 14 ATMOSPHERES. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: DURING ADVANCEMENT OF THE TREK BALLOON, RESISTANCE WAS NOTED. ADDITIONALLY, IT WAS NOTED THAT THE BALLOON WAS NOT SOAKED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0092163

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR