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 Transient Ischemic Attack (2109); Pericarditis (4448)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: mamchur s, chichkova t, khomenko e, kokov a.Pulmonary veins morphometric characteristics and spatial orientation influence on its cryoballoon isolation results.Diagnostics (basel).2022 may 26;12(6):1322.Doi: 10.3390/diagnostics12061322.Pmid: 35741132; pmcid: pmc9221566.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).

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: mamchur s, chichkova t, khomenko e, kokov a.Pulmonary veins morphometric characteristics and spatial orientation influence on its cryoballoon isolation results.Diagnostics (basel).2022 may 26;12(6):1322.Doi: 10.3390/diagnostics12061322.Pmid: 35741132; pmcid: pmc9221566.Objective/methods/study data: authors compared procedural and long-term outcomes in patients who underwent their first procedure of pulmonary vein isolation (pvi) for af with either radiofrequency ablation (rfa) (n = 108) or cba (n = 122; cryoballoon ablation) and assessed their interaction with the different pattern of pv anatomy, morphometric characteristics, and spatial orientation.A randomized, prospective, single-center controlled study was conducted, enrolling 230 patients with drug-refractory atrial fibrillation (af).Authors compared procedural and long-term outcomes of patients who underwent their first procedure of pulmonary vein isolation (pvi) for af with either radiofrequency ablation (rfa) (n = 108) or cba (n = 122) and assessed their interaction with the different pattern of pv anatomy, morphometric characteristics, and spatial orientation.The study period was between january 2018 and may 2021.This complaint captures the reported adverse events for the rfa group that utilized biosense products.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch catheter other biosense webster devices that were also used in this study: carto 3 concomitant non-biosense webster devices that were also used in this study: n/a (the cryoballoon group consisted of unidentified device manufacturers).Adverse event(s) and provided interventions (rf group that utilized smarttouch catheter): qty 2 tias - (no further information provided) interventions are not specified; qty 1 pericarditis - interventions are not specified; qty 1 hemopericardium (associated with transseptal puncture - sheath and puncture devices are not identified) - treated with drainage.

• 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: 15272942
• MDR Text Key: 298386699
• Report Number: 2029046-2022-01954
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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: 08/03/2022
• 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
• Patient Outcome(s): Life Threatening