Model Number 1012270-08 |
Device Problems
Material Separation (1562); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a lesion in the tortuous obtuse marginal (om) coronary artery.The mini trek balloon catheter was advanced but had difficulties crossing the lesion due to the patient anatomy.After multiple attempts trying to cross the lesion, the balloon crossed and the balloon was inflated without issue.During removal of the balloon catheter into a non-abbott guiding catheter, there was no reported resistance.But the proximal shaft separated in the guiding catheter.The separated portion was easily removed from the guiding catheter.There were no patient effects reported.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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A visual and functional inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance could not be tested as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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