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 Rupture (2208); Cardiac Tamponade (2226); Heart Block (4444)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: asatryan b, seiler j, bourquin l, knecht s, servatius h, madaffari a, baldinger sh, badertscher p, küffer t, spies f, tanner h, kühne m, osswald s, roten l, sticherling c, reichlin t.Pre-procedural arrhythmia burden and the outcome of catheter ablation of idiopathic premature ventricular complexes.Pacing clin electrophysiol.2021 apr;44(4):703-710.Doi: 10.1111/pace.14211.Epub 2021 mar 15.Pmid: 33675240.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: asatryan b, seiler j, bourquin l, knecht s, servatius h, madaffari a, baldinger sh, badertscher p, küffer t, spies f, tanner h, kühne m, osswald s, roten l, sticherling c, reichlin t.Pre-procedural arrhythmia burden and the outcome of catheter ablation of idiopathic premature ventricular complexes.Pacing clin electrophysiol.2021 apr;44(4):703-710.Doi: 10.1111/pace.14211.Epub 2021 mar 15.Pmid: 33675240.Objective/methods/study data: this study includes 254 patients who underwent idiopathic premature ventricular complexes ablation between 2013 and 2019 at two tertiary referral centers were retrospectively included.All procedures were performed using irrigated-tip ablation catheters and a 3d electro-anatomical mapping system.Sustained ablation success was defined as a =80% reduction of pre-procedural premature ventricular complexes burden determined by 24h-holter at follow-up.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool or thermocool sf or thermocool smarttouch concomitant other biosense webster devices that were also used in this study: carto3, paso concomitant non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: procedural complications occurred in seven patients (3%): qty 5: cardiac tamponade.Qty 1: complete atrioventricular block.Qty 1: aortic valve perforation.

Manufacturer Narrative

Manufacturer's reference number: (b)(4) during an internal review on 08-apr-2022, it was noted that the correct alert date is (b)(6)2022, instead of the previously noted date of (b)(6)2022.Therefore, a new bwi article summary guidance form has been attached with a corrected awareness date of (b)(6)2022.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13930361
• MDR Text Key: 288048127
• Report Number: 2029046-2022-00643
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031/S034
• 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,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 04/08/2022
• 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: CARTO3; PASO
• Patient Outcome(s): Life Threatening