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 Pseudoaneurysm (2605)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: bisignani a, pannone l, bala g, kazawa s, calburean p, overeinder i, et al.Repeat procedures for recurrent persistent atrial fibrillation: a propensity-matched score comparison between left atrial linear ablation with radiofrequency and posterior wall isolation with the cryoballoon.J arrhythmia.2021;00:1¿8.Https://doi.Org/10.1002/joa3.12614 since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not 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: bisignani a, pannone l, bala g, kazawa s, calburean p, overeinder i, et al.Repeat procedures for recurrent persistent atrial fibrillation: a propensity-matched score comparison between left atrial linear ablation with radiofrequency and posterior wall isolation with the cryoballoon.J arrhythmia.2021;00:1¿8.Https://doi.Org/10.1002/joa3.12614 objective and methods: aim of the current study was to compare the mid-term clinical outcome of left atrial posterior wall isolation (lapwi) obtained with cb-a with a left atrial roof and mitral isthmus lines obtained with radiofrequency catheter ablation (rfca) in patients with persistent af undergoing a redo af ablation procedure.A total of 100 patients were included in this study: 50 in the lapwi and 50 in the rfca group.Of note, the devices used in the lapwi group were all competitor products.The noted biosense webster devices were only used in the rfca group.This complaint will only capture the adverse evets associated with the rfca group.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: open irrigated tip catheter with contact-force (cf) monitoring: thermocool, smarttouch, biosense webster.Other biosense webster devices that were also used in this study: carto 3, biosense webster.Pentaray, biosense webster.Non-biosense webster devices that were also used in this study: all associated with the lapwi procedure.15 fr sheath (flexcath advance, medtronic).Inner lumen mapping catheter (mc; achieve, medtronic).28 mm cb-a (arctic front advance, medtronic).Circa¿s s-cath esophageal temperature monitoring system (circa scientific).Navx, st.Jude medical.Long-sheath (sl-0, st.Jude medical).Open irrigated tip catheter with contact-force (cf) monitoring: tacticath, endosense, (b)(6) medical adverse event(s) and provided interventions: 1 pseudoaneurysm requiring surgical treatment.

• 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: 12580424
• MDR Text Key: 279532705
• Report Number: 2029046-2021-01677
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• 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): Required Intervention