BIOSENSE WEBSTER INC. CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 00001111 number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Event Description
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It was reported that a patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation (afib) with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium where a hemostatic valve separation occurred.It was reported that when the dilator was introduced the hemostatic valve was very stiff with lots of resistance.Once dilator was in patient body the dilator bled blood back.The sheath was replaced, and the issue resolved.The valve did not break into pieces nor did it detach from the sheath.It is unknown if air entered the patient¿s body.Percutaneous or surgical removal was not required.The blood loss was 10-20ml, so hemodynamics was not compromised and medical intervention was not required.No report of patient consequence.Since the patient¿s hemodynamics was not compromised and no interventions were required to stop the bleed, this will not be considered a patient adverse event but a product malfunction.
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Search Alerts/Recalls
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