BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24630 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2021 |
Event Type
malfunction
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Event Description
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It was reported that a white hair was present on the opened kit.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During removal of the cutting balloon, a piece that looks like a white hair was noticed in the opened kit, on the catheter table.The device was discarded at the facility and there was no evidence of damage noticed, after use.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was not returned for analysis.A sample of foreign material (fm) was returned for analysis.A microscopic examination found the sample to have a synthetic appearance and measured approximately 40mm.Ftir analysis was carried out on the fm which confirmed its composition to be an 80% match to polyethylene terephthalate (pet).No other issues were identified during analysis.
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Event Description
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It was reported that a white hair was present on the opened kit.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During removal of the cutting balloon, a piece that looks like a white hair was noticed in the opened kit, on the catheter table.The device was discarded at the facility and there was no evidence of damage noticed, after use.There were no patient complications reported.
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Search Alerts/Recalls
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