MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problem Thrombosis (2100)

Event Date 09/30/2017

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 lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.No: (b)(4).

Event Description

This complaint is from a literature source titled "impact of the temporal relationship between atrial fibrillation and heart failure on prognosis after ablation " this prospective observational study was undertaken at kansai rosai hospital between december 2014 and september 2017.The participants were 129 consecutive patients with a history of heart failure (hf) requiring any therapeutic intervention and who were planned to undergo catheter ablation of atrial fibrillation (af).The patients were divided into 2 groups based on the temporal relationship between af and hf, with group 1 consisting of patients with af following hf, and group 2 of the remaining patients including those with af preceding hf or who developed both of them simultaneously at the time of first visit to a doctor.No fatal procedure-related complications occurred.The following complication was reported in this publication: it was reported that 1 patient underwent who radiofrequency catheter ablation of af procedure utilizing the thermocool smarttouch 3.5 mm tip suffered an intestinal thromboembolism within 30 days of ablation.The patient underwent conservative treatment and recovered.This patient was from group 2.Model and catalog number are not available, but the suspected device is thermocool smarttouch 3.5 mm tip.Other biosense webster devices that were also used in this study: carto3 non-biosense webster devices that were also used in this study: agilis® or sl0® sheath publication details objective: the purpose of this study was to elucidate the effect of the temporal relationship between atrial fibrillation (af) and heart failure (hf) on clinical outcomes after catheter ablation.Methods: we included 129 consecutive patients with af and hf who underwent catheter ablation in hospital from december 2014 to september 2017.The patients were divided into 2 groups based on the temporal relationship between af and hf.Group 1 consisted of 42 patients with af following hf while group 2 consisted of 87 patients with af preceding hf or those who developed both of them simultaneously at the timing of first visit to a doctor.The primary endpoint was a composite of death and hospitalization due to hf during a 2-year follow-up.No further information available.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10463570
• MDR Text Key: 204738832
• Report Number: 2029046-2020-01112
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention