Model Number H7493926216350 |
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 03/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant city: (b)(6).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 preparation of a 3.50 x 16 synergy¿ drug-eluting stent, it was noted that the device had a bad strut.The device never entered the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was good.
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Manufacturer Narrative
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Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr: 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 and pulled distally.The undamaged 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 microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the inner/outer and mid-shaft section found no issues along the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.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 preparation of a 3.50 x 16 synergy¿ drug-eluting stent, it was noted that the device had a bad strut.The device never entered the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was good.
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Search Alerts/Recalls
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