BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2212341 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05756
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE CATHETER NOTED CONTRAST IN THE LOOSELY FOLDED BALLOON AND IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE BALLOON HAVING BEEN INFLATED. THE DISTAL SHAFT WAS NECKED PROXIMAL TO THE PROXIMAL SEAL. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE STRETCHED SHAFT MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. AN INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON BELOW THE RATED BURST PRESSURE (RBP) AND FLUID WAS OBSERVED LEAKING AT A PINHOLE IN THE BALLOON OVER THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. THERE WERE NO SCRATCHES VISIBLE. SCANNING ELECTRON MICROSCOPY ANALYSIS NOTED THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LONGITUDINAL LEAK WAS ALONG A FOLD/CREASE. LONGITUDINAL LINES WERE OBSERVED ON THE OUTER SURFACE OF THE BALLOON AND MECHANICAL DAMAGE WAS OBSERVED AT AND NEAR THE LEAK. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. THE PATIENT ANATOMY WAS REPORTEDLY MODERATELY CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. HOWEVER, IT IS POSSIBLE THAT THE BALLOON WAS DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS COULD NOT BE CONFIRMED. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF ST ELEVATION AND THE RELATIONSHIP, IF ANY, TO THE DEVICE, COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY, RESISTANCE WAS FELT DURING ADVANCEMENT OF A 2.50X15 RX TREK DILATATION CATHETER, DUE TO CALCIFICATION. AN INITIAL ATTEMPT WAS MADE TO INFLATE THE BALLOON AT THE TARGET LESION; HOWEVER, THE BALLOON WOULD NOT INFLATE. PRESSURE WAS INCREASED TO 4-6 ATMOSPHERES; HOWEVER, THE BALLOON DID NOT INFLATE AND BALLOON RUPTURE WAS SUSPECTED. THE PATIENT DEVELOPED ST ELEVATIONS. THE CATHETER WAS REMOVED FROM THE ANATOMY AND AN UNSPECIFIED PLANNED STENT WAS DEPLOYED. AFTER DEPLOYMENT OF THE STENT, ST ELEVATIONS NORMALIZED. THE PROCEDURE WAS COMPLETED. THERE WITH NO ADVERSE PATIENT SEQUELA OR SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN STATED THAT THE ST ELEVATIONS OCCURRED DUE TO RUPTURE OF THE BALLOON. 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 0102663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE WIRE: RUNTHROUGHGUIDE CATH: HEARTRAIL