BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2080447 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03249
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH BLOOD ON THE FULL LENGTH OF THE CATHETER, CONSISTENT WITH BEING ADVANCED INTO THE ANATOMY. THERE WAS NO CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED; SUGGESTING POSITIVE PRESSURE MAY HAVE BEEN APPLIED. ALTHOUGH NOT REPORTED, THE SHAFT WAS SEPARATED 20 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE JAGGED. THE SHAFT WAS BUNCHED BETWEEN THE STRAIN RELIEF TUBING AND THE SEPARATION, SUGGESTING RESISTANCE MAY HAVE BEEN ENCOUNTERED WITH THE GUIDE WIRE. THE DISTAL END OF THE SHAFT, INCLUDING THE BALLOON, WAS BUNCHED 6 MM PROXIMAL TO THE DISTAL END OF THE CATHETER FOR A LENGTH OF 27 CM. THE INNER MEMBER AND BALLOON WERE BENT 12 CM PROXIMAL TO THE DISTAL END OF THE TIP, LIKELY DUE TO HANDLING. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE NON-ABBOTT GUIDE WIRE USED DURING THE PROCEDURE WAS RETURNED. THE GUIDE WIRE WAS CUT AND 50 CM OF THE DISTAL END REMAINS FROZEN IN THE GUIDE WIRE LUMEN, WHICH IS NOT CONSISTENT WITH THE REPORTED INFORMATION THAT THERE WAS NO RESISTANCE NOTED. FACTORS THAT MAY CONTRIBUTE TO THE RESISTANCE BETWEEN BALLOON CATHETER AND GUIDE WIRE MAY INCLUDE, BUT ARE NOT LIMITED TO, PRODUCT PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, OR DAMAGE TO THE DISTAL SHAFT OF THE BALLOON CATHETER. OTHER FACTORS MAY ALSO CONSIST OF ANATOMICAL CONDITIONS, SUCH AS TORTUOUS VESSELS, AS THEY COULD CAUSE THE SHAPE OF THE GUIDE WIRE OR CATHETER TO BECOME ANGLED AND MAKE IT MORE DIFFICULT TO ADVANCE THE CATHETER OVER THE WIRE. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE CATHETER. IN CERTAIN CIRCUMSTANCES, SUCH AS MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCES CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND COULD LEAD TO RESISTANCE. IN THIS CASE, IT APPEARS THAT RESISTANCE LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY, AS A RESULT, CONTINUED ATTEMPTS TO ADVANCE AGAINST RESISTANCE LIKELY CAUSED THE BUNCHING NOTED ON THE SHAFT. FURTHERMORE, IT IS LIKELY THAT DURING THE ATTEMPT TO REMOVE THE CATHETER FROM THE GUIDE WIRE WHILE FROZEN, THE SHAFT SEPARATED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, THE REPORTED DIFFICULTIES AND SUBSEQUENT DAMAGE TO THE ARMADA APPEAR TO BE RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY. ALL BALLOON CATHETERS ARE SUBJECT TO A 100% VISUAL INSPECTION. ADDITIONALLY, THE PROFILE DIMENSIONS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE.

    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 WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ANTERIOR TIBIALIS ARTERY WAS PERFORMED BY TRANSPEDAL APPROACH USING A NON-ABBOTT GUIDE WIRE AND THE ARMADA DILATATION CATHETER. THE BALLOON CATHETER BECAME ACCORDIONED WHILE INTRODUCING IT OVER THE GUIDE WIRE. IT WAS REPORTED THAT THERE WAS RESISTANCE WITH THE NON-ABBOTT GUIDE WIRE. THE ARMADA SHAFT WAS CUT BY THE CLINICIAN FOR AN UNSPECIFIED REASON. A NEW ARMADA WAS USED TO TREAT THE LESION. NO PATIENT EFFECTS WERE REPORTED. MUTIPLE ATTEMPTS TO OBTAIN CLARIFICATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 690026

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: COOK