BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2083310 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03348
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    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. GUIDE WIRE: RUNTHROUGH FLOOPY; GUIDE CATH: HEQARATRAIL 6F JL3.5; STENT: 2.5 X 28 MM PROMUS, 3.0 X 38 MM TAXUS. 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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC DILATATION CATHETER NOTED CRYSTALLIZED CONTRAST VISIBLE IN THE INFLATION LUMEN AND A LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION AND THE BALLOON BEING INFLATED. THE INABILITY TO INFLATE/DEFLATE THE CATHETER MAY BE RELATED TO NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, LEAKS, DAMAGE TO THE BALLOON OR INFLATION LUMEN, INFLATION LUMEN OBSTRUCTION, CONTRAST CONCENTRATION, INFLATION TECHNIQUE, OR FROM AN INTERACTION WITH ACCESSORY DEVICES (INDEFLATOR, RHV, OR GC). POTENTIAL FACTORS THAT CAN CONTRIBUTE TO A LOOSE OR INTERMITTENT CONNECTION BETWEEN THE CATHETER AND INDEFLATOR MAY INCLUDE, BUT ARE NOT LIMITED TO, MATERIALS, LOOSE CONNECTIONS, DAMAGE TO THE HUB OF THE CATHETER, TO THE INDEFLATOR, OR AN INTERACTION WITH ACCESSORY DEVICES. THE FEMALE PORT OF THE HUB WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER. THERE WAS NO LEAK NOTED AT THE HUB AND THE INDEFLATOR DID NOT LOSE PRESSURE AS REPORTED. THE INDEFLATOR ROTATOR WAS CONNECTED TO THE HUB WITHOUT IT BEING LOOSE. THE BALLOON DID NOT INFLATE DUE TO THE CRYSTALLIZED CONTRAST. THE CONTRAST WAS DISSOLVED AND THE BALLOON INFLATED. THE INFLATION AND DEFLATION TIMES WERE MEASURED AND MET MANUFACTURING CRITERIA. IT IS LIKELY THE CONNECTION WITH THE INDEFLATOR USED IN THE PROCEDURE WAS NOT TIGHT, RESULTING IN THE NOTED LEAK AND THE DIFFICULTY INFLATING AND DEFLATING THE BALLOON. BASED ON THE ANALYSIS OF THE RETURNED CATHETER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. IT WAS NOTED DURING THE RETURNED DEVICE FUNCTIONAL TESTING THAT THE BALLOON DEFLATED FLAT. A FLAT BALLOON IS NOT UNCOMMON, ESPECIALLY WHEN DEFLATED OUTSIDE OF THE BODY AND IS CONSISTENT WITH MULTIPLE AND HIGH PRESSURE INFLATIONS. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR INFLATION/DEFLATION ISSUES, LEAKS OR LOOSE CONNECTIONS FOR THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. SINCE THE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED DIFFICULTY INFLATING/DEFLATING THE DEVICE, LEAK OR LOOSE CONNECTION AND DID NOT IDENTIFY ANY MALFUNCTION WITH THE RETURNED CATHETER, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED FOR DAMAGE AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY, INCLUDING FUNCTIONAL TESTING FOR BALLOON INFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DIRECT STENTING OF THE MILDLY TORTUOUS AND CALCIFIED, ECCENTRIC, 75% STENOSED LESION OF THE LEFT ANTERIOR DESCENDING ARTERY, THE 2.5 X 15 VOYAGER NC WAS USED FOR POST-DILATATION BUT LEAKED AROUND THE CONNECTION BETWEEN THE HUB AND SHAFT WHILE INFLATED AT 10 ATMOSPHERE (ATM). THE PHYSICIAN COULD INFLATE USING 12 ATMOSPHERE; HOWEVER, IT WAS DIFFICULT TO INFLATE AND THE DEFLATION WAS SLOW, BUT DEFLATED COMPLETELY. ADDITIONALLY, IT WAS NOTED THAT THE CONNECTION BETWEEN THE HUB AND THE INDEFLATOR WAS NOT TIGHT. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGHT REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0061161

    Patients

    Seq Age Sex Outcome Treatment
    1