MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF BI-DIRECTIONAL CATHETER

Model Number D-1314-00

Device Problem Insufficient Information (3190)

Patient Problem Infarction, Cerebral (1771)

Event Date 11/30/2015

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 during this study: lasso nav eco, and carto.(b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.The event reported two patients with spinal cerebral infarction (sci) in the apixaban group.None of these lesions were detected with mri (t1- and t2-weighted images, and fluid-attenuated inversion recovery) 1¿3 months after af ablation.Title: ¿apixaban versus warfarin for the prevention of periprocedural cerebral thromboembolism in atrial fibrillation ablation: multicenter prospective randomized study.¿ the purpose of this study was to assess the safety and efficacy of apixaban for the prevention of cerebral thromboembolism complicating af catheter ablation.The 200 patients were enrolled in the apixaban group.A 3.5-mm irrigated-tip ablation catheter (thermocool sf, biosense webster, inc.) was used in this study, however catalog and lot number are unknown.Concomitant products were used during this study: lasso nav eco, and carto.

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• Type of Device: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• 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: 5992259
• MDR Text Key: 56101854
• Report Number: 9673241-2016-00644
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 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-1314-00
• Device Catalogue Number: D131400
• Device Lot Number: UNKNOWN_D-1314-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2016
• 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
• Patient Age: 65 YR