Model Number H7493926248300 |
Device Problems
Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/16/2018 |
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 movement on balloon occurred.A 3.00 x 48 synergy¿ drug-eluting stent was selected for use.However, when the stent was opened during preparation it was partially off the wire.The procedure was completed with another synergy stent.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., eval summary attached, method codes, result codes, and conclusion codes updated.Device updated by mfr.: stent delivery system was returned for analysis.A visual examination of the stent found that the distal end of the stent was damaged with stent struts stretched and pulled in a distal direction over the distal tip.The stent did not move on the balloon as the proximal end of the stent was still tightly crimped onto the balloon.The undamaged crimped stent od (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 multiple hypotube kinks along the full length of the catheter.This type of damages is consistent with excessive force being applied to the delivery system.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 movement on balloon occurred.A 3.00 x 48 synergy¿ drug-eluting stent was selected for use.However, when the stent was opened during preparation it was partially off the wire.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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