MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) GENERIC-EZ STEER TCOOL NONNAV THR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1295-00

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 12/31/2014

Event Type  Injury  

Manufacturer Narrative

Event description: 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, 3 patients excessive bruising in ¿f-8¿ group, 1 patient excessive groin bruising require protamine 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.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 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) g1.Contact office and manufacturing site should reflect: (b)(4).The devices were not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that two patients with symptomatic, drug refractory atrial fibrillation in control group under catheter ablation.These two patients suffered large hematomas which require intervention.The author assessed the events were not device related but procedure related.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, these events are 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, 1 patients bleeding need blood transfusion in control group, 12 patients excessive bruisings in control group.

• Brand Name: GENERIC-EZ STEER TCOOL NONNAV THR
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 5058319
• MDR Text Key: 25112562
• Report Number: 9673241-2015-00608
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1295-00
• Device Catalogue Number: D129500
• Device Lot Number: UNKNOWN_EZ_STEER_TC_NNAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR