MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109)

Event Date 09/23/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: greco ca, albanese m, pisanò ec, garzya m, donateo m, nicolardi s, scotto di quacquaro a, mangia f, de razza l, casali g, zaccaria s.Left atrial intramural hematoma: the role of echocardiography.Echocardiography.2021 oct;38(10):1821-1827.Doi: 10.1111/echo.15198.Epub 2021 sep 23.Pmid: 34555196.Objective/methods/study data: report of a case of 47 year old man that experienced left atrial intramural hematoma that followed a catheter ablation procedure and was complicated by cardiac and cerebral ischemia and required cardiac surgical management.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 3.5 mm irrigation tib ablation catheter navistar thermocool.Concomitant 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: sl1 sheath (st.Jude medical).Adverse event(s) and provided interventions: dysarthria and right arm hyposthenia related to atrial hematoma treated by surgical intervention (neurologic deficits resolved within 10 days after intervention).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: greco ca, albanese m, pisanò ec, garzya m, donateo m, nicolardi s, scotto di quacquaro a, mangia f, de razza l, casali g, zaccaria s.Left atrial intramural hematoma: the role of echocardiography.Echocardiography.2021 oct;38(10):1821-1827.Doi: 10.1111/echo.15198.Epub 2021 sep 23.Pmid: 34555196.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.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: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14710408
• MDR Text Key: 294852254
• Report Number: 2029046-2022-01331
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• 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: SL1 SHEATH (ST. JUDE MEDICAL); UNK_CARTO 3
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male