BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2242243 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06246
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX TREK CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE TIGHTLY FOLDED BALLOON CONSISTENT WITH PREPARATION. THERE WAS A BEND IN THE DISTAL PORTION OF THE HYPOTUBE 10 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. THE TIP LENGTH AND 2/3 COLLAPSED BALLOON PROFILE WERE MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. IT WAS REPORTED THAT STENTING COULD NOT BE PERFORMED DUE TO THE OCCURRENCE OF AN ANEURYSM. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: HT CROSS IT 100; INFLATION: EVEREST; GUIDE CATH: XB 3.5 6F; SHEATH: 6F THE DEVICE IS BEING RETURNED, BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN CROSSED WITH A TREK 2.5X20 IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY WITH SOFT, TIGHT LESION BUT COULDN'T CROSS THROUGH. THEREAFTER, HE USED A MINI TREK 1.5X15 WHICH SAILED THROUGH SUCCESSFULLY BUT WITHOUT STENTING DUE TO OCCURRENCE OF ANEURYSM. THERE WAS NO REPORT OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE BECAUSE OF THE FAILURE TO CROSS. ADDITIONAL INFORMATION: "TREK DID NOT CAUSE/CONTRIBUTE TO THE OCCURRENCE OF ANEURYSM AND THIS IS NOT PRE-EXISTING". BASED ON THE INFORMATION RECEIVED STATING THAT THE ANEURYSM WAS NOT PREEXISTING, AND BASED ON THE LACK OF TIME TO ACQUIRE FURTHER INFORMATION, THE INCIDENT HAS BEEN UPGRADED TO REPORTABLE. IF THE ANEURYSM WAS NOT PREEXISTING AND THE TREK BALLOON CATHETER WAS IN THE VESSEL, THERE IS A CHANCE IT DID CAUSE OR CONTRIBUTE TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1051362

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other