MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 03/05/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: yano m, egami y, ukita k, kawamura a, nakamura h, matsuhiro y, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, nishino m, tanouchi j.Clinical impact of right ventricular-pulmonary artery uncoupling on predicting the clinical outcomes after catheter ablation in persistent atrial fibrillation patients.Int j cardiol heart vasc.2022 mar 5;39:100991.Doi: 10.1016/j.Ijcha.2022.100991.Pmid: 35281759; pmcid: pmc8904595.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.# (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: yano m, egami y, ukita k, kawamura a, nakamura h, matsuhiro y, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, nishino m, tanouchi j.Clinical impact of right ventricular-pulmonary artery uncoupling on predicting the clinical outcomes after catheter ablation in persistent atrial fibrillation patients.Int j cardiol heart vasc.2022 mar 5;39:100991.Doi: 10.1016/j.Ijcha.2022.100991.Pmid: 35281759; pmcid: pmc8904595.Objective/methods/study data: background: right ventricular (rv)-pulmonary artery (pa) uncoupling is associated with poor outcomes in heart failure patients.They aimed to elucidate the relationship between rv-pa uncoupling and late arrhythmia recurrence after ablation in persistent atrial fibrillation (peraf) patients whose phenotypes have impaired right ventricular function and pulmonary hypertension.Methods: the present study included 203 peraf patients from the osaka rosai atrial fibrillation ablation (oraf) registry who underwent an initial ablation.We assigned the patients based on the value of tricuspid annular plane systolic excursion (tapse)/pulmonary artery systolic pressure (pasp) ratio that could predict late recurrence of af/atrial tachycardia (lraf) as an indicator of rv-pa uncoupling.We evaluated the following factors: the difference in the relationship between taspe/pasp before ablation and incidence of lraf among the 2 groups stratified by tapse/pasp based on the above cut-off value and tapse/pasp change from before to one-year after ablation.Results: a receiver operating characteristic curve analysis revealed a good accuracy of predicting lraf by tapse/pasp ratio with a cutoff of 0.57.The patients with tapse/pasp ratios = 0.57 had a significantly greater lraf risk than tapse/pasp ratios > 0.57.A multivariate cox proportional hazards analysis showed that tapse/pasp (hr 0.12, 95% ci; 0.019¿0.724, p = 0.026) was independently and significantly associated with lraf.The tapse/pasp significantly improved more one-year after the ablation than before (p = 0.016).Conclusion: rv-pa uncoupling was independently associated with lraf, independent of left atrial function, and significantly improved more one-year after the ablation than before in peraf patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense webster concomitant devices that were also used in this study: carto3.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: there were a total of two adverse events reported in this literature article: (2) patients suffered phrenic nerve palsy.There was no note of required interventions or prolonged hospitalization.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 14695039
• MDR Text Key: 294016096
• Report Number: 2029046-2022-01316
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• 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: UNK_CARTO 3
• Patient Outcome(s): Other