COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number A35HPV12040080 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Occlusion (1984); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The physician was attempting to treat a 40mm calcified lesion located in the left proximal common iliac artery with a fortrex pta balloon catheter.A 7f non-medtronic sheath and a 0.35 guidewire were used for the procedure.The lesion exhibited a severe degree of tortuosity and a severe degree of calcification with an unknown % lesion stenosis.The diameter of the artery is 12mm.Embolic protection was not used.The balloon was inflated using an inflation device using 50/50 fluid.The device was prepped per the ifu with no issues identified.The device passed through a previously deployed stent but no resistance was encountered when advancing the catheter and excessive force was not used.It was reported the balloon catheter detached/cracked/fractured and the balloon stripped off during removal from a patient.The break/fracture occurred at the balloon catheter and the detached portion of the device remained in the patient.The physician used bronchoscopy forceps during the procedure to remove what he believed to be all the remnants left in the body.Several hours post procedure, an ultrasound determined a flow defect.The patient experienced vessel occlusion due to the device component which remained in the left proximal common iliac artery.The patient was brought back to the operating theatre to stent the flow defect which was believed to be a remnant of the balloon.The physician stated that the products performed as expected and that the event was due to the anatomical difficulties of the case.
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