BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2182997 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05371
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 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. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: WHISPER. INFLATION: MERIT. GUIDE CATH: 7 FR. RHV: COPILOT. SHEATH: 7 FR. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON, CONSISTENT WITH PREPARATION AND A LEAK WHILE IN THE PATIENT ANATOMY. THE BALLOON HAD RELAXED FOLDS. THERE WERE BENDS IN THE DISTAL SHAFT 3 CM, 4.1 CM AND 6 CM PROXIMAL TO THE PROXIMAL SEAL. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS 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 LEAK. USING A NEW INDEFLATOR, NEGATIVE PRESSURE WAS APPLIED AND THERE WAS A FLOW OF BUBBLES IN THE INDEFLATOR. THE BALLOON CATHETER WAS PRESSURIZED TO 4 ATMOSPHERES AND FLUID LEAKED FROM THE GUIDE WIRE EXIT NOTCH AND THE TIP. WITH A MANDREL IN THE GUIDE WIRE EXIT NOTCH, THE TOP OF THE INFLATION LUMEN WAS CUT DISTALLY FOR A LENGTH OF 6 MM. THERE WAS A TEAR IN THE INNER MEMBER 4 MM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 1 MM. THERE WAS A SCRATCH ON THE INNER MEMBER DISTAL TO THE TEAR FOR A LENGTH OF 1 MM. THE BALLOON DID NOT INFLATE BECAUSE OF THE TEAR IN THE INNER MEMBER. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE INNER MEMBER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE GUIDE WIRE. TO HELP ENSURE THAT THIS DAMAGE IS NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR DAMAGE, INCLUDING AT THE POINT WHERE THE CATHETER IS INSERTED INTO THE PACKAGING COIL. ADDITIONALLY, ALL PRODUCTS ARE 100% LEAK TESTED PRIOR TO PACKAGING AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE CATHETER BODY INTEGRITY PRIOR TO RELEASE. IN THIS CASE, THERE WAS NO DAMAGE NOTED DURING THE INSPECTION PRIOR TO USE OR DURING PREPARATION WHICH SUGGESTS THE INNER MEMBER WAS NOT PREVIOUSLY DAMAGED. IT IS LIKELY THAT THE GUIDE WIRE INTERACTED WITH THE INNER MEMBER DURING BACK LOADING, RESULTING IN THE NOTED TEAR IN THE INNER MEMBER. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR LEAKS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE NOTED TEAR IN THE INNER MEMBER APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINI TREK BALLOON WAS TRACKED INTO THE MID LEFT ANTERIOR DESCENDING ARTERY WITH NO PROBLEMS; HOWEVER, WHEN THE BALLOON CATHETER WAS CONNECTED TO THE INFLATION DEVICE, A BACK-FLOW OF BLOOD WAS SEEN COMING INTO THE BALLOON SHAFT. THE DEVICE WAS REMOVED FROM THE PATIENT. ANOTHER 1.5 X 15 MM MINI TREK WAS USED SUCCESSFULLY AND THE MID VESSEL WAS STENTED WITH NO FURTHER COMPLICATIONS NOTED. NO PATIENT ADVERSE EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1012061

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR