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	Cardiac Tamponade (2226); Ischemic Heart Disease (2493)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: yalin k, soysal au, aksu t, onder se, ozturk s, yalman h, mutlu d, ercan ot, ikitimur b, cimci m, durmaz e, karadag b, bilge ak, huang h, karpuz h.Safety and efficacy of coronary angiographic image integration tool-guided ablation of left sided outflow tract ventricular arrhythmias.J interv card electrophysiol.2024 jan;67(1):31-34.Doi: 10.1007/s10840-023-01619-4.Epub 2023 aug 14.Pmid: 37578671.Objective/methods/study data: authors investigated the safety and efcacy of iit-guided ablation of left-sided outfow tract ventricular arrhythmias (va) and compared to simultaneous conventional angiography (sca).The article reports vascular access site complication requiring surgery and these are associated with the use of sheaths at femoral access sites.The article does not identify sheaths.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool ablation catheter concomitant biosense webster devices that were used in this study: carto 3 non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions possibly associated with unidentified thermocool ablation catheter: qty 1 transient anterior st elevation which resolved spontaneously (elevated st segment) (recognized procedural complication) qty 1 pericardial effusion requiring pericardiocentesis during gcv ablation (cardiac tamponade) (recognized procedural complication).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: yalin k, soysal au, aksu t, onder se, ozturk s, yalman h, mutlu d, ercan ot, ikitimur b, cimci m, durmaz e, karadag b, bilge ak, huang h, karpuz h.Safety and efficacy of coronary angiographic image integration tool-guided ablation of left sided outflow tract ventricular arrhythmias.J interv card electrophysiol.2024 jan;67(1):31-34.Doi: 10.1007/s10840-023-01619-4.Epub 2023 aug 14.Pmid: 37578671.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: 18927050
• Report Number: 2029046-2024-00897
• Device Sequence Number: 21173404
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 03/18/2024

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: Not provided
• Initial Report FDA Received Date: 03/18/2024
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown