BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2854952 · Received December 3, 2012

    Report

    Report Number
    2134265-2012-07338
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE AVAIL. FOR EVALUATION, RETURNED TO MANUFACTURER ON, DEVICE RETURNED TO MANUFACTURE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THERE WAS SOLIDIFIED CONTRAST IN THE BALLOON AND INFLATION LUMEN. THE PROXIMAL CONE OF THE BALLOON WAS BUNCHED. THE INNER SHAFT WAS BUCKLED INSIDE AND AT THE EDGE OF THE MANIFOLD. THE INNER AND OUTER SHAFT WERE BUCKLED ADJACENT TO THE PROXIMAL BALLOON BOND. THE GUIDEWIRE WAS PROTRUDING 28CM FROM THE DISTAL TIP. GENTLY PULLING ON THE WIRE CONFIRMED THAT THE WIRE WAS STUCK IN THE LUMEN OF THE CATHETER. THE OUTER DIAMETER OF THE WIRE WAS WITHIN SPECIFICATION. THE CATHETER WAS LOCKED-UP ON THE GUIDEWIRE AND THE BALLOON WAS BUNCHED IN THE AS RECEIVED CONDITION. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2012-07423. IT WAS REPORTED THAT DURING AN INTERVENTION PROCEDURE, THE CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE POPLITEAL-TIBIAL ARTERY. A PLATINUM PLUS GUIDE WIRE WAS SELECTED AND WITH DIFFICULTY IT WAS INTRODUCED INTO THE POPLITEAL ARTERY, ONCE THE GUIDE WIRE HAD BEEN INTRODUCED THE PHYSICIAN SELECTED THIS 2 MM X 40 MM X 144 CM COYOTE BALLOON CATHETER AGAIN THERE WAS DIFFICULTY ADVANCING TO THE TARGET LESION. THE DOCTOR OBSERVED THAT THE BALLOON WASN'T REALLY SLIPPERY ON THE GUIDE WIRE. AFTER INFLATION OF THE BALLOON, THE PHYSICIAN HAD A LOT OF DIFFICULTY WITHDRAWING THE BALLOON AND KEEPING THE GUIDE WIRE IN THE POPLITEAL THEN, THE BALLOON BECOME STUCK ON THE GUIDE WIRE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WITHDREW THE GUIDE WIRE AND BALLOON CATHETER AT THE SAME TIME. WHEN THE BALLOON CATHETER WAS OUTSIDE OF THE PATIENT, THE PHYSICIAN SAW THAT THE BALLOON WAS CRUSHED AND THE GUIDE WIRE WAS STILL STUCK INSIDE THE BALLOON. IT WAS FURTHER REPORTED THAT "THE TEAM THOUGHT THAT THIS GUIDE WIRE WAS JUST TOO BIG FOR THIS BALLOON CATHETER". ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2012-07423. IT WAS REPORTED THAT DURING AN INTERVENTION PROCEDURE, THE CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE POPLITEAL-TIBIAL ARTERY. A PLATINUM PLUS GUIDE WIRE WAS SELECTED AND WITH DIFFICULTY IT WAS INTRODUCED INTO THE POPLITEAL ARTERY, ONCE THE GUIDE WIRE HAD BEEN INTRODUCED THE PHYSICIAN SELECTED THIS 2MM X 40MM X 144CM COYOTE BALLOON CATHETER AGAIN THERE WAS DIFFICULTY ADVANCING TO THE TARGET LESION. THE DOCTOR OBSERVED THAT THE BALLOON WASN'T REALLY SLIPPERY ON THE GUIDE WIRE. AFTER INFLATION OF THE BALLOON, THE PHYSICIAN HAD A LOT OF DIFFICULTY WITHDRAWING THE BALLOON AND KEEPING THE GUIDE WIRE IN THE POPLITEAL THEN, THE BALLOON BECOME STUCK ON THE GUIDE WIRE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WITHDREW THE GUIDE WIRE AND BALLOON CATHETER AT THE SAME TIME. WHEN THE BALLOON CATHETER WAS OUTSIDE OF THE PATIENT, THE PHYSICIAN SAW THAT THE BALLOON WAS CRUSHED AND THE GUIDE WIRE WAS STILL STUCK INSIDE THE BALLOON. IT WAS FURTHER REPORTED THAT "THE TEAM THOUGHT THAT THIS GUIDE WIRE WAS JUST TOO BIG FOR THIS BALLOON CATHETER". ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134204010 15155211

    Patients

    Seq Age Sex Outcome Treatment
    1