Model Number H7493952824220 |
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 05/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).
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Event Description
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It was reported that stent damage occurred.During unpacking of a 2.25x24mm promus premier¿ drug-eluting stent, it was noted that a stent strut was pulled up.The device never entered the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: the stent delivery system was returned for analysis.A visual examination of the stent found that the first proximal stent row was damaged with stent struts lifted.The undamaged crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.A visual and microscopic examination of the tip found no damage.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 device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the device found no issues along the mid shaft, inner or outer shaft polymer extrusion.No other issues were identified during the product 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 2.25x24mm promus premier¿ drug-eluting stent, it was noted that a stent strut was pulled up.The device never entered the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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