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); Transient Ischemic Attack (2109); Pericardial Effusion (3271)

Event Date 08/15/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: pillarisetti j, reddy m, vodapally m, annapureddy t, molugu m, atkins d, bommana s, pimentel r, dendi r, lakkireddy d.Comparison of peri-procedural anticoagulation with rivaroxaban and apixaban during radiofrequency ablation of atrial fibrillation.Indian pacing electrophysiol j.2020 nov-dec;20(6):261-264.Doi: 10.1016/j.Ipej.2020.08.002.Epub 2020 aug 15.Pmid: 32810538; pmcid: pmc7691779.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 no lot number was provided by the customer.Literature article cannot be attached as the electronic file size is too large.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: pillarisetti j, reddy m, vodapally m, annapureddy t, molugu m, atkins d, bommana s, pimentel r, dendi r, lakkireddy d.Comparison of peri-procedural anticoagulation with rivaroxaban and apixaban during radiofrequency ablation of atrial fibrillation.Indian pacing electrophysiol j.2020 nov-dec;20(6):261-264.Doi: 10.1016/j.Ipej.2020.08.002.Epub 2020 aug 15.Pmid: 32810538; pmcid: pmc7691779.Objective/methods/study data:prospective studies on rivaroxaban and apixaban have shown the safety and efficacy of direct anticoagulation agents (doac)s used peri-procedurally during radiofrequency ablation (rfa) of atrial fibrillation (af).We thus sought to compare the two agents in the peri procedural setting with regards to bleeding and thromboembolic complications.Data was obtained from a prospective observational registry maintained at one academic institution where a large volume of atrial fibrillation ablations are performed every year.There were a total of 358 patients (n ¼ 56 on apixaban and n ¼ 302 on rivaroxaban).There were no differences in baseline characteristics between both groups.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 3.5-mm open irrigated tip catheter (thermocool, biosense webster inc.Concomitant other biosense webster devices that were also used in this study: lasso, biosense webster inc., concomitant non-biosense webster devices that were also used in this study: spiral, st.Jude medical.Adverse event(s) and provided interventions: qty: 5; one patient had a tia and one patient had an ischemic stroke in the rivaroxaban group in 60 days; pericardial effusion between both groups (one patient in the apixaban group (1.7%) and two in the rivaroxaban group (0.6%)) with p ¼ 0.4.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13690281
• MDR Text Key: 286742525
• Report Number: 2029046-2022-00476
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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 NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• 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: LASSO NAV 2515,22P SPLITHANDLE; SPIRAL, ST. JUDE MEDICAL
• Patient Outcome(s): Life Threatening