MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 01/31/2015

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.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Conconmitant products were used during this study: carto 3 system; pentaray nav; 64-element, 5.5¿10.0 mhz, soundstar; decanav; navistar, navistar thermocool, thermocool sf (b)(4).The device was not returned to bwi.

Event Description

This event is from a literature source.It was reported that two patients developed cerebrovascular accident.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: epicardial radiofrequency ablation failure during ablation procedures for ventricular arrhythmias reasons and implications for outcomes the purpose of this study was to characterize the reasons for epicardial ablation failure after successful epicardial access, to relate these to the targeted epicardial area, and to assess implications of failed or limited epicardial rfa on outcome for va ablation procedures.The study was conducted between january 1999 and january 2015.Suspected device is the irrigated thermocool smart-touch, however catalog and lot number are unknown.Should more information be received, product for this adverse event will be modified as appropriate.Conconmitant products were used during this study: carto 3 system; pentaray nav; 64-element, 5.5-10.0 mhz, soundstar; decanav; navistar, navistar thermocool, thermocool sf the awareness date for this complaint is 9/06/2016 because the article was reviewed on 09/6/2016.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5991672
• MDR Text Key: 56104780
• Report Number: 9673241-2016-00637
• Device Sequence Number: 1
• Product Code: DRF
• 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
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1336-00
• Device Catalogue Number: D133600
• Device Lot Number: UNKNOWN_D-1336-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/30/2016
• 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; Required Intervention
• Patient Age: 57 YR