BIOSENSE WEBSTER, INC. (JUAREZ) GENERIC-EZ STEER TCOOL NONNAV THR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
|
Back to Search Results |
|
Model Number D-1295-00 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Bruise/Contusion (1754); Hematoma (1884)
|
Event Date 12/31/2014 |
Event Type
Injury
|
Manufacturer Narrative
|
Event description continue: 1 patients bleeding need blood transfusion in control group, 12 patients excessive bruisings in control group, 7 patients small hematomas in control group, 18 patients slightly bled which require femostop in control group, 1 patient arterial pseudoaneurysm in ¿f-8¿ group, 2 patients large hematoma in ¿f-8¿ group, 3 patients excessive bruising in ¿f-8¿ group, 1 patient excessive groin bruising require protamine in ¿f-8¿ group, 4 patients small hematoma in ¿f-8¿ group.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.Concomitant products were used during this study: lasso circular mapping catheter, carto mapping system.Other company¿s devices were used during this study: 11.5-fr transseptal steerable sheaths (agilis, st.Jude medical), intracardiac echocardiographic catheter (acuson, siemens), navx mapping system (st.Jude medical), femostop compression assist device (st jude medical) (b)(4).The devices were not returned to bwi.
|
|
Event Description
|
This complaint is from a literature source.It was reported that one patient with symptomatic, drug refractory atrial fibrillation in "f-8" group under catheter ablation.In this patient, the suture repeatedly broke at the time of tying the knot.Manual compression was applied immediately for hemostasis and maintained for 30-40 min, and protamine was administered to reverse heparin effects.The patient developed excessive groin bruising but no hematomas or other vascular complications.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: "venous hemostasis postcatheter ablation of atrial fibrillation while under therapeutic levels of oral and intravenous anticoagulation." the purpose of this study was to evaluate the safety and efficacy of the "figure-of-eight" ("f-8") suture technique for femoral venous hemostasis while on therapeutic doses of intravenous anticoagulation at the time of sheath removal.The study conducted between july 2009 and december 2014.Suspected device is irrigated-tip ablation catheter thermocool , however catalog and lot number are unknown.Other serious and non-serious adverse events were reported in this article (serious events are reported to fda separately): 2 patients transient ischemic attacks in control group, 3 patients arterial pseudoaneurysms in control group, 8 patients large hematomas in control group (continue).
|
|
Search Alerts/Recalls
|
|
|