Model Number H7493925124300 |
Device Problems
Bent (1059); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that stent damage occurred.During unpacking of a 24x3.00mm promus premier¿ drug-eluting stent, it was noted that the stent strut was lifted up.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: promus premier ous mr 24 x 3.00mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified distal stent damage.Distal stent struts were lifted.The undamaged mid-stent crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip revealed no issues.No other issues were identified during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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Event Description
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It was reported that stent damage occurred.During unpacking of a 24x3.00mm promus premier drug-eluting stent, it was noted that the stent strut was lifted up.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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