Model Number D-1327-01-S |
Device Problems
Material Protrusion/Extrusion (2979); Positioning Problem (3009); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation procedure with a thermocool smarttouch bi-directional navigation catheter and a deflection issue occurred.The catheter could not be deflected as intended during left pulmonary vein isolation.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.This event was originally assessed as not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.The biosense webster failure analysis lab received the device for evaluation on november 5, 2015 and during visual inspection it was discovered that there was a small bump on lumen shaft with small tear exposing metal from the inside of the lumen shaft.The small bumps are not mdr reportable; however, the finding of metal exposed is reportable because it poses a risk to the patient.The awareness date for this record is november 5, 2015 because that is when the damage was discovered.
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Manufacturer Narrative
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(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® bi-directional navigation catheter and a deflection issue occurred.Upon receiving, the catheter was visually inspected and it was found that tip lumen material had a bump with metal exposed, which is why this complaint was reported to the fda.An x-ray image was taken from the area and it was noticed that the t-bar had slid down getting caught and exposed at tip lumen transition.Per the event reported the catheter was tested for deflection and the catheter failed due to the t-bar sliding down from its place.An internal corrective action was created to address the t-bar issue.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.
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Search Alerts/Recalls
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