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

Catalog Number UNK_THERMOCOOL SF NON NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Transient Ischemic Attack (2109)

Event Date 11/30/2014

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.Radiofrequency versus cryoballoon ablation for atrialfibrillation in the setting of left common pulmonary veins.Pmid: 31579929 doi: 10.1111/pace.13810.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.Manufacturer's reference number: (b)(4).

Event Description

This complaint is from a literature source.Radiofrequency versus cryoballoon ablation for atrialfibrillation in the setting of left common pulmonary veins.Pmid: 31579929 doi: 10.1111/pace.13810.Objective/methods/study data: the aim of this study was to compare the performance of radiofrequency (rf) versus second-generation cryoballoon (cb-a) ablation in patients with atrial fibrillation (af) and lcpvs.Methods: between january 2009 and november 2014, in a total cohort of 716 patients undergoing pv isolation with preprocedural ctscanning, lcpv+ patients were selected with measurement of pv ostial area and trunk distance.All lcpv+ patients were matched between rf (radiofrequency) and cryoballoon (cb-a) ablation group in a 1:1 ratio based on propensity scores, and compared for outcome.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermo- cool smarttouchcatheter, thermocool catheter other biosense webster devices that were also used in this study: lasso, carto; biosensewebster inc non-biosense webster devices that were also used in this study: adverse event(s) and provided interventions: one patient has experienced a femoral pseudo-aneurysm with requirement of intervention.One patient has experienced a transient ischemic attack that occurred postprocedure.

• Brand Name: THERMOCOOL® SF 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13689387
• MDR Text Key: 289506861
• Report Number: 2029046-2022-00474
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/07/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NON NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/08/2022
• 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: CARTO, BIOSENSEWEBSTER INC; LASSO, BIOSENSEWEBSTER INC
• Patient Outcome(s): Other