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
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Paralysis (1997); Paresis (1998)
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: yano m, egami y, kawanami s, sugae h, ukita k, kawamura a, nakamura h, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, nishino m, tanouchi j.Relationship between pre-procedural non-ischemic st-segment depression and the clinical outcomes after catheter ablation in persistent atrial fibrillation patients.J cardiol.2023 may;81(5):456-463.Doi: 10.1016/j.Jjcc.2023.02.004.Epub 2023 feb 21.Pmid: 36822545.Objective/methods/study data: background: st-segment depression suggests the presence of coronary artery disease (cad) during sinus rhythm, but the clinical significance, including the outcomes after catheter ablation (ca), in atrial fibrillation (af) patients remain unknown.Methods: the present study included persistent af (peraf) patients from the osaka rosai atrial fibrillation ablation (oraf) registry who underwent an initial ablation and had no history of cad.We assigned the patients based on the presence of st-segment depression before ca and evaluated the impact of relevant factors on stsegment depression and the relationship between st-segment depression, including leads locations (anterior leads, inferior leads, and lateral leads) or depression type (upsloping, horizontal, and downsloping) or the degree of st-segment depression and late recurrence of af (lraf).Results: this study population included a total of 551 patients of whom 189 had st-segment depression.The median follow-up duration was 397 days and lraf occurred in 195 patients.By multiple regression analysis, diabetes mellitus, hemoglobin, brain natriuretic peptide, left ventricular ejection fraction, and left atrial diameter were significant determinants of st-segment depression before ca.Kaplan-meier analysis demonstrated that the patients with st-segment depression had a significantly greater risk of lraf than those without (p < 0.001).Multivariate cox proportional hazards analysis showed st-segment depression was independently and significantly associated with a higher risk of lraf (p < 0.001).The patients with st-segment depression =0.15 mv had a significantly higher risk of lraf than those with st-segment depression =0.15 mv (p < 0.001).No significant differences among the st-segment depression lead locations and st-segment depression type were observed.Conclusion: non-ischemic st-segment depression during af rhythm was significantly associated with lraf post ca in peraf patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch concomitant biosense webster devices that were used in this study: carto concomitant non-biosense webster devices that were also used in this study: n/a the pseudoaneurysm reported in the article is associated with sheath used for vascular access, which was not identified in this study.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch qty 4 phrenic nerve palsy with unknown intervention (diaphragmatic paralysis) (adverse event) qty 2 gastroparesis with unknown intervention (gastroparesis) (adverse event).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: yano m, egami y, kawanami s, sugae h, ukita k, kawamura a, nakamura h, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, nishino m, tanouchi j.Relationship between pre-procedural non-ischemic st-segment depression and the clinical outcomes after catheter ablation in persistent atrial fibrillation patients.J cardiol.2023 may;81(5):456-463.Doi: 10.1016/j.Jjcc.2023.02.004.Epub 2023 feb 21.Pmid: 36822545.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 no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 ref #: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19238753
• Report Number: 2029046-2024-01455
• Device Sequence Number: 8072642
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown