MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Paralysis (1997); Cardiac Tamponade (2226)

Event Date 09/23/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: heinroth k, blum t, drexler m, plehn a, hartkopf t, horenburg c, sedding d.X-ray exposure in cryoballoon versus radiofrequency ablation for atrial fibrillation over 7 years: a single center study.J arrhythm.2022 sep 23;38(6):1017-1027.Doi: 10.1002/joa3.12780.Pmid: 36524039; pmcid: pmc9745457.Abstract: background: facing an increasing number of radiofrequency ablation (rf) and cryoballoon ablation (cb) procedures for treatment of af radiation exposure and its reduction is a focus point for interventional electrophysiologists.Objective: this study evaluated the procedural parameters of the different ablation methods focusing on radiation exposure and the bmi of the patients.Methods: one thousand one hundred and thirty-three first procedural cases of pulmonary vein isolation in patients with paroxysmal and persistent af treated with rf and cb-based techniques were analyzed retrospectively over a period of 7 years focusing on the endpoints dose area product (dap, cgycm2 ), fluoroscopy time (ft, min) and procedural time (pt, min).Results: of the 1133 patients (mean age 63.4 ±11.4 years, bmi 28.9 ±4.7) 335 patients received an rf procedure, 211 patients were treated with the cryoballoon first generation (cb1), and 587 patients with cryoballoon second generation (cb2), respectively.The mean dap for the pvi was 508±654 cgycm2 in rf procedures, 1077±683 cgycm2 in cb1-procedures, and 587±489 cgycm2 in cb2-procedures with fluoroscopy times significantly shorter in rf procedures (9.6 ±5.2 min) as compared to 17.7 ±5.9 min in cb1- and 16.3 ±6.3 min in cb2-procedures (p <.001).At the same time, the procedure duration using rf (115±33.5 min) was significantly longer than both in cb1 (96±16.8 min) and cb2 procedures (75±15.9 min).Conclusions: despite longer fluoroscopy durations in the cb technique, the cb2 resulted in a comparable low radiation exposure in pvi as compared to rf, accompanied by shorter procedure durations.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: thermocool smarttouch other biosense webster devices that were also used in this study: carto 3, lasso mapping catheter non-biosense webster devices that were also used in this study for rf ablation: 6 f quadripolar steerable catheter (dynamic xt®, boston scientific), 5-f quadripolar catheter (cournand-curve, supreme®, st.Jude medical).Non-biosense webster devices that were also used in this study for cryoballoon ablation was performed with a steerable 6 f quadripolar catheter (dynamic xt®, boston scientific); 6-f quadripolar catheter (cournand-curve, supreme®, st.Jude medical); e sheath-dilator-complex (fast cath® sl0, 63cm, and brk1-needle®, 71cm: st.Jude medical); 12-f-flexcath® or flexcath advance® sheath (medtronic); 10-polar achieve® (medtronic); cryoballoon (28mm diameter) arctic front® (cb1) or arctic front advance® (cb2).Adverse event(s) and provided interventions for the rf ablation group: qty 10 pericardial tamponade (interventions not discussed in article) qty 2 phrenic nerve palsy (all phrenic nerve palsies disappeared within 12 months; interventions not discussed in article).Qty 2 ateriovenous fistula (interventions not discussed in article and no reported deaths).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: heinroth k, blum t, drexler m, plehn a, hartkopf t, horenburg c, sedding d.X-ray exposure in cryoballoon versus radiofrequency ablation for atrial fibrillation over 7 years: a single center study.J arrhythm.2022 sep 23;38(6):1017-1027.Doi: 10.1002/joa3.12780.Pmid: 36524039; pmcid: pmc9745457.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16440247
• MDR Text Key: 310231431
• Report Number: 2029046-2023-00386
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• 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: 5-F QUADRIPOLAR CATHETER (COURNAND-CURVE, SUPREME.; 6F QUADRIPOLAR STEERABLE CATHETER DYNAMIC XT.; UNK_CARTO 3.; UNK_LASSO.
• Patient Outcome(s): Life Threatening