BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY
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Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that the wire was fractured.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A rotawire was selected to treat the entire length of the vessel.The 2.00mm peripheral rotalink plus made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off and remained behind on the guidewire.It was also noted that the rotawire fractured when the burr was rotating.Snares were used to remove the burr successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.
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Manufacturer Narrative
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Corrected d1 brand name from rotablator rotational atherectomy system to peripheral rotawire and wireclip torquer.Corrected d2a common device name from catheter, coronary, atherectomy to catheter, peripheral, atherectomy.Corrected d2b pro code (product code) from mcx to mcw.
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Event Description
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It was reported that the wire was fractured.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A rotawire was selected to treat the entire length of the vessel.The 2.00mm peripheral rotalink plus made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off and remained behind on the guidewire.It was also noted that the rotawire fractured when the burr was rotating.Snares were used to remove the device successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.
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