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

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 01/01/2021

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 following literature cite has been reviewed: mavilakandy a., sidhu b., man s., antoun i., vali z., de almeida t.P., li x., lazdam m., ibrahim m., chins., sandilands a., stafford p., somani r., ng a.A tertiary centre experience comparing new temperature-controlled high-power short duration ablation technology with standard radiofrequency and cryo-energy ablation.Heart.2021 jun; conference: british cardiovascular society annual conference, 'cardiology and the environment'.Virtual.107 (suppl 1) :a84-a85.Objective: pulmonary vein isolation (pvi) is an established treatment strategy for atrial fibrillation (af).Radiofrequency (rf) ablation technology has evolved over the last decade with the very high-power short-duration(vhpsd) temperature- controlled ablation approach emerging as the latest development.The purpose of this study was to determine the procedural efficacy, metrics and safety of vhpsd ablation with conventional power-controlled rf(pcrf) ablation and cryoenergy ablation (cryo).Methods/study data: a prospective single tertiary center analysis was performed on patients undergoing first time pvi ablation from 2019 to 2020.The population was divided in to 4treatment arms; qmode plus (vhpsd), qmode (qmode), pcrf using thermocool smarttouch sf catheter (stsf) and cryo.Demographics, clinical and procedural metrics such as pvi duration, ablation time and sedation requirement were collated.Patients were monitored for perioperative complications.Results one hundred patients underwent ablation with 25 cases conducted in each arm.Complete pvi was attained in all study subjects.No adverse procedural events were recorded for the vhpsd while 2 pericardial effusions occurred in the pcrf group, 1 cardiac tamponade in the qmode group and 2 transient ischemic attacks in the cryo group.Conclusion with the emergence of vhpsd rf ablation, preliminary findings indicate significant potential in reduction of procedural and ablation time.Further analysis is ongoing in order to ascertain longer-term efficacy and patient safety.The manufacturer of the device used to perform the cryo is unknown, and assumed to be a bwi thermocool product.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: q mode plus ablation catheter for vhpsd q-mode ablation catheter for vhpsd thermocool smarttouch sf catheter for pcrf thermocool cryo other biosense webster devices that were also used in this study: n/a non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions: 1 cardiac tamponade in the q-mode group- no treatment specified 2 pericardial effusions in thermocool smarttouch group- no treatment specified 2 tias in the cyo group- no treatment specified.".

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL SF
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12389421
• MDR Text Key: 268897960
• Report Number: 2029046-2021-01441
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2021
• Initial Date FDA Received: 08/30/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other