MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 01/16/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Investigation summary : since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate 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.

Event Description

This complaint is from a literature source.The literature article titled, "minimizing radiation exposure in catheter ablation of ventricular arrhythmias" written by matevz jan, david zizek, tine prolic kalinsek, dimitrij kuhelj, primoz trunk, tadeja kolar, jus ksela, martin rauber and mehmet yazici published by bmc cardiovascular disorders 2021 jun 16;21(1):306.Doi: 10.1186/s12872-021-02120-4.Pmid: 34134637; pmcid: pmc8210369.Was reviewed.Model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: uni-directional irrigated tip thermocool smarttouch and smarttouch sf ablation catheters in group 1; pentaray multipolar catheter for high-density mapping in patients with shd (structural heart disease) in group 2.Other biosense products utilized in study: carto 3d eam system (mapping), acuson acunav (intra-cardiac echocardiography), non-biosense products utilized in study: navx precision (abbott mapping), agilis long sheath 9abbott), flexibility ablation catheters (abbott).Exact quantities of involved products cannot be accurately determined as the article does not specify which specific ablation catheters are associated with each adverse event.The following adverse event(s) were reported in this publication in table 3 captured under procedural complications: group one: one patient had perforation of rv (treated surgically).Group one: one patient had late pericardial tamponade (treated with percutaneous drainage).Group two: one patient had pseudo-aneurysm of left femoral artery (treated surgically).Objective: aim was to analyze procedural outcomes with fluoroscopy minimizing approach for treatment of vas in patients with structurally normal hearts (snh) in group 1 and structural heart disease (shd) in group 2.Methods: fifty-two (age 53.4±17.8 years, 38 male, 14 female) consecutive patients who underwent ca of vas in the institution between may 2018 and december 2019 were included.Procedures were performed primarily with the aid of the three-dimensional electro-anatomical mapping system and intra-cardiac echocardiography.Fluoroscopy was considered only in left ventricular (lv) summit mapping for coronary angiography and when epicardial approach was planned.Acute and long-term procedural outcomes were analyzed.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Notification for (b)(4) submitted on 08/26/2021 that the correct date for "g3.Date received by manufacturer" is also 08/03/2021 in addition to b4.Date of this report of 08/03/2021.B4.Date of this report 08/03/2021.

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12372453
• MDR Text Key: 268427343
• Report Number: 2029046-2021-01395
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

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: No Information
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS LONG SHEATH; FLEXABILITY ABLATION CATHETERS; NAVX PRECISION
• Patient Outcome(s): Required Intervention