BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24702 |
Device Problems
Material Puncture/Hole (1504); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/22/2021 |
Event Type
malfunction
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Event Description
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It was reported that the guidewire perforated the catheter shaft.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was selected for percutaneous transluminal angioplasty (pta).The 99% stenosed, severely calcified and severely tortuous lesion was located in an artery below the knee (btk).There was difficulty advancing the balloon through the lesion.The balloon was removed to exchange for a lower profile balloon.During removal, they observed the non-boston scientific guidewire was protruding through the shaft proximal to the balloon.The procedure was completed with another device.There were no patient complications.
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Manufacturer Narrative
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Device eval by mfr: the returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the shaft.Microscopic examination revealed a hole in the guidewire lumen and inflation lumen 34mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that the guidewire perforated the catheter shaft.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was selected for percutaneous transluminal angioplasty (pta).The 99% stenosed, severely calcified and severely tortuous lesion was located in an artery below the knee (btk).There was difficulty advancing the balloon through the lesion.The balloon was removed to exchange for a lower profile balloon.During removal, they observed the non-boston scientific guidewire was protruding through the shaft proximal to the balloon.The procedure was completed with another device.There were no patient complications.
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