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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Cardiac Tamponade (2226)

Event Date 02/28/2011

Event Type  Injury  

Manufacturer Narrative

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.Concomitant products were used during this study: lasso circular mapping catheter, carto mapping system other company¿s devices were used during this study: conventional transthoracic echocardiographic evaluations (vivid 9, ge vingmed ultrasound, (b)(4) or sonos 5500, philips medical systems), computed tomography (ct) (somatom definition flash, siemens healthcare), navx (st jude medical).(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.(b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that one patient with nonvalvular atrial fibrillation underwent radiofrequency catheter ablation.The patient suffered postprocedural stroke.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: "prognostic implications of right and left atrial enlargement after radiofrequency catheter ablation in patients with nonvalvular atrial fibrillation." the purpose of this study was to assess structural changes in right atrium and left atrium and determine their association with recurrence of af after radiofrequency catheter ablation (rfca).The study was conducted between 2009 and 2011.Suspect device is a 3.5-mm irrigated-tip thermocool catheter, 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): 1 patient cardiac tamponade.5 patients hematomas.

• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5097477
• MDR Text Key: 26557213
• Report Number: 9673241-2015-00667
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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: 09/08/2015
• 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): Life Threatening
• Patient Age: 57 YR