Model Number 9552 |
Device Problems
Contamination (1120); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that contamination occurred.A 28 x 2.25 promus premier drug-eluting stent was selected for use.However, the package was found to be damaged when it was unpacked and the sterility of the device was compromised.The procedure was completed with another of same device.There were no patient complications nor injuries reported and patient status was stable.
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Event Description
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It was reported that contamination occurred.A 28 x 2.25 promus premier drug-eluting stent was selected for use.However, the package was found to be damaged when it was unpacked and the sterility of the device was compromised.The procedure was completed with another of same device.There were no patient complications nor injuries reported and patient status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: promus premier ous mr stent delivery system catheter was returned for analysis.A visual examination of the stent found stent damage.Stent struts on the distal end were lifted and pulled distally.The undamaged stent od was measured using snap gauge and the result was within max 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 distal tip damage.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during analysis.
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Search Alerts/Recalls
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