BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; SIMILAR DEVICE NI75TCJH, PMA # P030031
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Model Number D-1197-00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ischemia (1942)
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Event Date 12/31/2010 |
Event Type
Injury
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Manufacturer Narrative
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No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided] by the customer.Since the lot number is unknown, the full udi number cannot be provided.Concomitant products were used during this study: lasso circular mapping catheter; carto 3 mapping system.Other company¿s devices were used during this study: 1.5 t scanner (1.5 tesla magnetom avanto, siemens), 8f long sheath (fast-cath, st.Jude or swartz left 0, st.Jude-sl0).(b)(4).
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Event Description
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This complaint is from a literature source.It was reported that one patient with paroxysmal atrial fibrillation underwent cardiac ablation procedure.Post-procedural cerebral mri unveiled asymptomatic ischemic lesions.The lesion was localized in the right frontal cortex.The lesions dimension was 6mm.The neurological examination and carotid doppler was repeated just after the post ablation cerebral mri and it resulted negative.Based on the facts of the case and the author's assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title: "impact of ablation catheter irrigation design on silent cerebral embolism after radiofrequency catheter ablation of atrial fibrillation: results from a pilot study." the purpose of this study was to compare procedural parameters and safety of pulmonary vein isolation (pvi) performed by using open-irrigated catheters with different irrigation design.The study was conducted between october 2010 and december 2010.Other adverse events were reported in this article: 1 patient one asymptomatic ischemic lesion (dimention 2mm) localized in the left occipital cortex; 1 patient two asymptomatic ischemic lesions (dimention 3 and 4 mm, respectively) localized in the left frontal cortex; 1 patient one asymptomatic ischemic lesion (dimention 5mm) localized in the right parietal cortex; 1 patient two asymptomatic ischemic lesions (dimention 3 and 7 mm, respectively) localized both in the left cerebellum.Suspected device is navistar thermocool ablation catheter, however catalog and lot number are unknown.
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