MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Cardiac Tamponade (2226); Stenosis (2263)

Event Date 08/01/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: bai jian xu wei li xiaohong shen wenzhi liu yu chen qian gu rong ling gao.A retrospective study on the efficacy of contact force catheter and second-generation cryoballoon ablation in the treatment of persistent atrial fibrillation.Translated chinese published article.Chinese journal of interventional cardiology 2020 year 8 month day 28 volume no.8 period chin j intervent cardiol, august 2020, vol 28, no.8.Doi: 10.3969/j.Issn.1004-8812.2020.08.005.Objective/methods/study data: to compare the efficacy and safety of contact force catheter and second-generation cryoballoon ablation in the treatment of persistent atrial fibrillation (af).A total of 201 patients with persistent atrial fibrillation who received the first cf catheter or second-generation cryoballoon ablation in nanjing drum tower hospital, the affiliated hospital of nanjing university medical school from december 2016 to december 2018 were retrospectively and consecutively enrolled and divided into cf (contact force) catheter group (n = 146) and second-generation cryoballoon group (n = 55) according to different surgical methods used.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch contact force ablation catheter other biosense webster devices that were also used in this study: lasso mapping catheter, carto 3.Non-biosense webster devices that were also used in this study: cyroballow group: achieve mapping catheter (medtronic), cryoballoon (medtronic).Adverse event(s) and provided interventions (associated with ablation in the cf group): qty 1 ischemic stroke - no further information provided regarding interventions or outcome.Qty 1 vascular complication - no further information regarding specific injury/complication, interventions, or outcome.Qty 2 cardiac tamponade - no further information provided regarding interventions or outcome.Qty 1 pulmonary vein stenosis - no further information provided regarding interventions or outcome.

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: bai jian xu wei li xiaohong shen wenzhi liu yu chen qian gu rong ling gao.A retrospective study on the efficacy of contact force catheter and second-generation cryoballoon ablation in the treatment of persistent atrial fibrillation.Translated chinese published article.Chinese journal of interventional cardiology 2020 year 8 month day 28 volume no.8 period chin j intervent cardiol, august 2020, vol 28, no.8.Doi: 10.3969/j.Issn.1004-8812.2020.08.005.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15241482
• MDR Text Key: 298058236
• Report Number: 2029046-2022-01898
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2022

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 Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3; CRYOBALLOON (MEDTRONIC); LASSO MAPPING CATHETER; MAPPING CATHETER (MEDTRONIC)
• Patient Outcome(s): Life Threatening