BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24702 |
Device Problems
Contamination (1120); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that the device was contaminated.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was selected for use.However, the balloon was damaged and the reel appeared dirty.The procedure was completed with different device.No patient complications were reported.
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Event Description
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It was reported that the device was contaminated.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was selected for use.However, the balloon was damaged and the reel appeared dirty.The procedure was completed with different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual inspection revealed that the guidewire lumen within the balloon was curved with a "wavy" appearance and the balloon is deformed.There is blood present on the carrying tube.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
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Search Alerts/Recalls
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