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 Transient Ischemic Attack (2109)

Event Date 12/31/2015

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.Concomitant products were used in this study: duo-decapolar catheter, carto3 or xp system, lasso catheter, navistar or navistar thermocool or thermocool sf catheter, pentaray nav catheter, decanav catheter, soundstar catheter (b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.It was reported 5 female patients underwent radiofrequency ablation for sustained monomorphic vt and developed transient ischemic attack /stroke.Additional information was received indicating that the author did not recall any related to specific malfunction of bwi device.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: ¿a comparison of women and men undergoing catheter ablation for sustained monomorphic ventricular tachycardia.¿ the purpose of this study was to compare baseline, procedural and outcome data of women and men in a large cohort taking into account the type of underlying heart disease.Nine-hundred forty-eight (948) patients have been enrolled between january 2005 and december 2015.Suspect device is smarttouch thermocool catheter, however catalog and lot number are unknown.Concomitant products were used in this study: duo-decapolar catheter, carto3 or xp system, lasso catheter, navistar or navistar thermocool or thermocool sf catheter, pentaray nav catheter, decanav catheter, soundstar catheter.

Manufacturer Narrative

This report is to provide attachment of article (complaint source).(b)(4).

• 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: 6231328
• MDR Text Key: 64136119
• Report Number: 9673241-2017-00021
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR