MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 09/02/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: noiri ji, konishi h, matsuzoe h, sato s, azami t, teramura k.Giant thrombus in the left atrium after radiofrequency catheter ablation for atrial fibrillation: a case report.Heartrhythm case rep.2021 sep 2;7(11):773-775.Doi: 10.1016/j.Hrcr.2021.08.010.Pmid: 34820278; pmcid: pmc8602120.Objective/methods/study data: this report summarizes a rare case of brain infarction and amaurosis fugax (vision loss) due to a giant left atrial thrombus 3 months after radiofrequency catheter ablation (rfca) for atrial fibrillation (af) in an 81-year-old man.Cardiac thrombectomy revealed that the thrombus was on the ablation line, suggesting that the endothelial damage with rfca may have promoted thrombosis.This patient had essential thrombocythemia and advanced malignant cancer, both of which are risk factors for thromboembolism.This case suggests the importance of evaluation for the risk of thromboembolism after rfca, even in cases with adequate anticoagulation or nonrecurrence of af.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch surround flow other biosense webster devices that were also used in this study: n/a, non-biosense webster devices that were also used in this study: n/a, adverse event(s) and provided interventions: the patient experienced a thrombosis and a cerebrovascular accident requiring surgical intervention.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: noiri ji, konishi h, matsuzoe h, sato s, azami t, teramura k.Giant thrombus in the left atrium after radiofrequency catheter ablation for atrial fibrillation: a case report.Heartrhythm case rep.2021 sep 2;7(11):773-775.Doi: 10.1016/j.Hrcr.2021.08.010.Pmid: 34820278; pmcid: pmc8602120.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 not provided by the customer.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• 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: 14727864
• MDR Text Key: 294281636
• Report Number: 2029046-2022-01359
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NAV
• 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
• Patient Outcome(s): Life Threatening; Required Intervention