MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D-1327-00-S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Stroke/CVA (1770)

Event Date 05/31/2015

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 that used in this study:carto 3, lasso.Other company¿s devices that were used in this study: duo-decapolar catheter, 8.5fr sl-1 (b)(4).The device is not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 133 (4-fps group, n=57; 2-fps group, n=76) patients with atrial fibrillation disease underwent catheter ablation from january 2014 and may 2015.Among them, one patient had experienced a cerebellar stroke 1 day after the procedure, and achieved a full neurological recovery in the 2-fps group.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: ¿extremely low-frame-rate digital fluoroscopy in catheter ablation of atrial fibrillation a comparison of 2 versus 4 frame rate.¿ the purpose of this study was to comparison of 2 versus 4 frame rate.Suspect device is a thermocool smarttouch or navistar thermocool sf, however catalog and lot number is unknown.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, 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: 6775899
• MDR Text Key: 82113253
• Report Number: 9673241-2017-00635
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1327-00-S
• Device Catalogue Number: D132700
• Device Lot Number: UNKNOWN_D-1327-00-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2017
• 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: 58 YR