Model Number 3854 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that the shaft was separated.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon shaft separated.The device was completely removed from the patient and the procedure was completed.No patient complications reported.
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Manufacturer Narrative
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B3 date of event: date of event was approximated to 01/01/2024 as no event date was reported.
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Manufacturer Narrative
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B3 date of event: date of event was approximated to 01/01/2024 as no event date was reported.Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 57cm distal to the distal end of the strain relief.Hypotube kinks were also noted.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.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube shaft identified a break at 47cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted in various locations along the length of the hypotube shaft.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
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Event Description
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It was reported that the shaft was separated.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon shaft separated.The device was completely removed from the patient and the procedure was completed.No patient complications reported.
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Search Alerts/Recalls
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