Model Number B2060-200 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The other additional vascular device's referenced are being filed under a separate medwatch report number.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that three armada 35 percutaneous transluminal angioplasty (pta) catheters (5x200mm, 5x20mm, 6x200mm) and two absolute pro self-expanding stent systems (sess) (6x150mm, 6x60mm) were received by the customer with blood marks on the outside packaging.The devices were not used and there was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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Visual inspection and fourier-transform infrared spectroscopy (ftir) analysis were performed on the returned device.The reported complaint was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information reviewed and analysis of the returned device, the reported contamination appears to be due to case circumstances.The noted contamination (blood) was likely due to handling of the packaging at the account.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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