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 Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report number: 2029046-2021-00481 is related to the same incident.

Event Description

This complaint is from a literature source.The following complication was reported in this publication: it was reported that 1 patient underwent catheter ablation of atrial fibrillation and suffered pulmonary vein stenosis.Intervention was not reported.Model and catalog number are not available, but the suspected device is thermocool smart touch.Other biosense webster devices that were also used in this study: pentaray, lasso non-biosense webster devices that were also used in this study: beeat(japan), lifeline (abbott), inquiry (abbott).Publication details.Title: the effect of posterior wall isolation for persistent atrial fibrillation on recurrent arrhythmia.Objective: it is important to consider recurrent arrhythmia after catheter ablation for persistent atrial fibrillation (af) for planning an ablation strategy.However, the studies are limited to pulmonary vein isolation (pvi) plus posterior wall isolation (pwi), which were reported to improve procedural outcomes.The objective of this study is to evaluate the effect of pwi on recurrent arrhythmia.Methods: this is an observational study on patients with persistent af comparing pvi plus pwi and pvi only strategies.In pvi plus pwi group, linear ablation of the left atrium roofline and bottom line were performed to achieve pwi after pvi.Some patients with af recurrence underwent the second procedure.The presence of recurrent arrhythmia and results of the second procedures were evaluated.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 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: 11604587
• MDR Text Key: 243446254
• Report Number: 2029046-2021-00480
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BEEAT (JAPAN); INQUIRY (ABBOTT); LIFELINE (ABBOTT); UNK_LASSO; UNK_PENTARAY NAV
• Patient Outcome(s): Other
• Patient Age: 67 YR