BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE; INTRODUCER, CATHETER
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Model Number D138503 |
Device Problems
Material Separation (1562); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2021 |
Event Type
malfunction
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Event Description
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A patient underwent an atrial fibrillation ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve separation.It was initially reported by the customer that during an atrial fibrillation case, the physician was attempting to insert the dilator into a large-curve vizigo sheath, but was met with resistance.Unable to enter the dilator into the sheath, the nurse assisting the physician then tried flushing the sheath and was again met with resistance and unable to do so.A new sheath was used in it¿s place.The patient was not harmed, and the case was completed successfully without delay.The customer¿s reported ¿obstruction with the sheath" is not considered to be an mdr reportable malfunction since there is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however, the potential that it could cause or contribute to a death or serious injury, or other significant adverse event is remote.On 19-dec-2021, pal revealed that a visual inspection of the returned device found the hemostatic valve dislodged inside the hub of the device.This finding is considered to be an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on 19-dec-2021 and reassessed it as mdr reportable.
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Manufacturer Narrative
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Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned carto vizigo sheath sample revealed that the hemostatic valve was found dislodged inside of the hub.Microscopic examination in the hemostatic valve surface and showed evidence of stress marks on the outer diameter.The brim cap and the silicone ring were placed in the correct position and found in good conditions.A device history record was performed and no internal actions related to the reported complaint were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.However, due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to address this issue according to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.¿ 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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