ANGIOSCORE, INC. ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY
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Model Number 2200-2515 |
Device Problems
Break (1069); Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 02/17/2015 |
Event Type
Injury
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Event Description
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The physician accessed the right groin through the destination sheath to the left leg to treat the dp lesion.The physician chose an angiosculpt rx 2200-2515 to treat a short lesion since the hospital does not carry the angiosculpt otw 2039-2520.The physician felt that the angiosculpt otw 2039-2540 was too long.(the total working length of the rx is only 137 cm vs 155 cm on the otw 2039.) after insertion, it was found that it was not long enough to reach the lesion.Upon removal, the balloon ¿snapped¿ off and remained in the patient, inside the sheath.The physician then inserted a 0.018¿ guide wire through the sheath and was able to remove the sheath over this wire with the angiosculpt balloon.A short sheath was then placed in the groin and the procedure ended.The lesion remained untreated.
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Manufacturer Narrative
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During withdrawal, the angiosculpt device separated in the sheath.Additional intervention was required for removal, thus resulting in prolongation of the case.The angiosculpt device was returned in two pieces.The device separated at the intermediate shaft approximately 80 mm from the lacerated rx port.The intermediate shaft is necked and stretched at the separated ends and the hypotube is kinked.Based on the lab analysis, it is probable that the user applied some degree of force, resulting in the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.In addition, the device was used off-label in the peripheral.The angiosculpt catheter is indicated for use in the treatment of hemodynamically significant coronary artery.Placeholder.
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