MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NON NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NON NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Paralysis (1997); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is from a literature source.The following literature cite has been reviewed: sano m, heeger ch, sciacca v, grosse n, keelani a, fahimi bhh, phan hl, reincke s, brüggemann b, fink t, liosis s, vogler j, eitel c, tilz rr.Evaluation of predictive scores for late and very late recurrence after cryoballoon-based ablation of atrial fibrillation.J interv card electrophysiol.2021 aug;61(2):321-332.Doi: 10.1007/s10840-020-00778-y.Epub 2020 jul 7.Pmid: 32638187; pmcid: pmc8324624.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not 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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: sano m, heeger ch, sciacca v, grosse n, keelani a, fahimi bhh, phan hl, reincke s, brüggemann b, fink t, liosis s, vogler j, eitel c, tilz rr.Evaluation of predictive scores for late and very late recurrence after cryoballoon-based ablation of atrial fibrillation.J interv card electrophysiol.2021 aug;61(2):321-332.Doi: 10.1007/s10840-020-00778-y.Epub 2020 jul 7.Pmid: 32638187; pmcid: pmc8324624.Objective: studies on predictive scores for very late recurrence (vlr) (recurrence later than 12 months) after second-generation cryoballoon-based pulmonary vein isolation (cb2-pvi) are sparse.The purpose of this study was to evaluate the frequency of late recurrence (lr) (later than 3 months) and vlr, and to validate predictive scores for lr and vlr after initial cb2-pvi.Methods/study data: the present study population included a total of 393 af patients who underwent cb2-pvi from july 2015 to december 2017 at the university heart center lübeck.A total of 288 patients undergoing initial cb2-pvi (66 ± 11 years, 46% paroxysmal) were retrospectively enrolled in the lr cohort.In the vlr cohort, 83 patients with recurrence within 3-12 months or with < 12-month follow-up were excluded.The predictive scores of arrhythmia recurrence were assessed.During a mean follow-up of 15.3 ± 7.1 months, 188 of 288 (65.2%) patients remained in sinus rhythm without any recurrences.Thirty-two of 205 (15.6%) patients experienced vlr after a mean of 16.6 ± 5.6 months.Paf accounted for 133/288 (46%) patients and npaf for 155/288 (54%) patients.Npaf, hypertension, and bundle branch block were more frequent in patients with lr and vlr.During a mean follow-up of 15.3 ± 7.1 months, 188 of 288 patients (65.2%) remained in sinus rhythm without any recurrences including 17 patients on aads.In the 100 patients with recurrent arrhythmia, the median time to recurrence was 6 months.Procedure-related cardiac tamponade occurred in 2/288 (0.7%) patients that was managed with percutaneous drainage.Phrenic nerve palsy occurred in 10/288 (3.5%) patients, with 9 cases recovering during follow-up and 1 persisting at 12 months.Pericardial effusion occurred in 9 patients; the authors did not specify treatment for the effusions.The authors concluded that the mb-later score provided more reliable predictive value for both lr and vlr.Patients with higher mb-later scores may benefit from more intensive long-term follow-up.This complaint will capture all adverse events associated with bwi devices.Any adverse events associated with competitor or unknown products or attributed to the patient¿s preexisting conditions will be excluded.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 3.5-mm irrigated-tip catheter (thermocool sf) other biosense webster devices that were also used in this study: na non-biosense webster devices that were also used in this study: 8.5fr sheath (sl1, abbott) 12fr sheath (arctic front advance, medtronic) inner lumen mapping catheter (achieve, medtronic) adverse event(s) and provided interventions: 10 phrenic nerve palsy: 9 resolved and one persisting at 1 year follow-up.No treatment specified.2 cardiac tamponades treated with percutaneous drainage.9 pericardial effusions- treatment unspecified.

• Brand Name: UNK_THERMOCOOL SF NON NAV
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12609973
• MDR Text Key: 282040553
• Report Number: 2029046-2021-01731
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/11/2021

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
• Initial Date Manufacturer Received: 09/18/2021
• Initial Date FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12FR SHEATH (ARCTIC FRONT ADVANCE, MEDTRONIC); 8.5FR SHEATH (SL1, ABBOTT); INNER LUMEN MAPPING CATHETER (ACHIEVE, MEDTRONIC)
• Patient Outcome(s): Life Threatening; Required Intervention