Model Number THS-SS-CL |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907); Compatibility Problem (2960); Physical Resistance/Sticking (4012)
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Patient Problem
Injury (2348)
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Event Date 11/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician used a turbohawk directional atherectomy along with a non medtronic 6fr sheath and a medtronic 0.014 guide wire in procedure to treat a little calcified plaque lesion in the left proximal posterior tibial artery with 90% stenosis.The vessel is moderately tortuous.The vessel diameter and lesion length are 3 mm and 80 mm respectively.The vessel was not pre dilated but post dilated.The ifu was followed during preparation, procedure and post procedure.During withdrawal there was moderate resistance felt and tip damaged, the tip broke where it was twisted for cleaning.It was reported that after atherectomy was performed in the left pta and the device was being removed, physician noticed resistance with the device with entering the 6fr crossover sheath.Physician noticed a prolapse in the.014 nitrex guide wire.After straightening the wire, device entered the sheath.Upon removal of the device, it was noticed that the tip of the nosecone was not present on the device.Physician looked at the end of the sheath under the magnified fluoroscopy and saw the tip still on the wire.There was a stenosis that was going to be stented during procedure, physician decided to stent the tip to the wall in the external iliac artery.An angioplasty of the lesion in the left pta that previously had atherectomy performed on.Subsequently, arteriography showed inline flow to the foot.
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Manufacturer Narrative
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Product analysis: the turbohawk device was returned to the medtronic investigation lab for analysis.No ancillary devices or images were returned with the device.Cutter driver not returned.Biological debris throughout housing.Rotating distal tip detached but not returned.Tecothane remains intact.Bend noted in the housing from the proximal end to distal end.Microscopic inspection revealed substance consistent with dried blood covering the cutter window.Dried blood was removed for inspection.It was noted the cutter was returned just distal to the cutter window.Inspection of the guide wire lumen revealed the proximal end of the lumen was torn proximally.Zipper tearing was observed throughout the remainder of the housing lumen.No anomalies were observed with the rotating distal tip joint.The returned device was connected to a cutter driver from the lab.Retracted the cutter into the cutter window.Biological debris and contrast were noted on the cutter; no further anomalies were noted.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: three passes were performed with the turbohawk.The cutter was inside the housing when the device was removed from the patient.The tip of the turbohawk was stented to the external iliac artery using a visipro balloon expandable stent.Angioplasty was carried out using a chocolate balloon on the lesion in the left posterior tibial artery, that previously had atherectomy performed on.Patient is in a stable condition and has been discharged from the hospital.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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