MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 12/31/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).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.Biosense webster manufacturer's report numbers: 2029046-2020-01318, 2029046-2020-01319.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 2 patients underwent catheter ablation of atrial fibrillation and suffered femoral artery pseudoaneurysm.Intervention was required puncture, suction and compression.Model and catalog number are not available, but the suspected device is thermocool smarttouch® catheter.Other biosense webster devices that were also used in this study: carto 3, pentaray catheter, carto visitag¿ module non-biosense webster devices that were also used in this study: none publication details: title: single transseptal puncture technique and contact force catheter: a simplified ablation strategy for paroxysmal atrial fibrillation objective: the present study aimed to evaluate the safety and efficacy of an optimized single transseptal puncture technique and contact force sensing atrial fibrillation (af) radiofrequency catheter ablation (rfca) strategy within a clinical setting.Methods: fast anatomic mapping and contact force sensing ablation was applied to patients with paroxysmal af (paf) ablation between september 2014 and december 2016 using a single trans-septal sheath.Pulmonary vein isolation (pvi) and linear ablation were performed in paf individually with a 10-20 g contact force with minimal fluoroscopy.Stimulation with 10 ma outputs on the lesions without capture was used as endpoint.A total of 419 consecutive patients who underwent first-time rfca were enrolled in the current study, and acute pvi was achieved in all patients.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: UNK
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10581317
• MDR Text Key: 208951434
• Report Number: 2029046-2020-01320
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• 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: 09/08/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR