Lot Number 0032134034 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 3.50 x 32mm synergy megatron drug-eluting stent was advanced for treatment.However, during the procedure, the stent catheter was broken.The device was removed completely intact from the patient, and the procedure was completed with another of the same device.There were no patient complications reported.
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 3.50 x 32mm synergy megatron drug-eluting stent was advanced for treatment.However, during the procedure, the stent catheter was broken.The device was removed completely intact from the patient, and the procedure was completed with another of the same device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr: synergy megatron mr us 3.50 x 32mm was returned to the complaint investigation site (cis).A visual, tactile and microscopic examination of the hypotube shaft identified a break in the device at 25.8cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.There was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed signs of distal tip damage (flared).
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Search Alerts/Recalls
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