MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	UNK_PENTARAY NAV
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770); Pericarditis (4448)
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: tijskens m, abugattas jp, thoen h, strazdas a, schwagten b, wolf m, de greef y.Adding electroanatomical mapping to cryoballoon pulmonary vein isolation improves 1-year clinical outcome and durability of pulmonary vein isolation: a propensity score-matched analysis.J cardiovasc dev dis.2024 feb 6;11(2):57.Doi: 10.3390/jcdd11020057.Pmid: 38392271; pmcid: pmc10889252.Objective/methods/study data: background: adding electroanatomical left atrial (la) voltage mapping to cryoballoon ablation (cba) improves validation of acute pulmonary vein isolation (pvi).Aims: to determine whether the addition of mapping can improve outcome and pvi durability.Methods: one-year outcome and pv reconnection (pvr) rate at first repeat ablation were studied in 400 af patients in a propensity-matched analysis (age, af type, cha2ds2-vasc score) between achieve catheter-guided cba with additional ensite la voltage maps performed pre- and post-cba (mapping group; n = 200) and ct- and achieve catheter-guided cba (control group; n = 200).Clinical success was defined as freedom of documented af or atrial tachycardia (at) > 30 s.Pv reconnection patterns were characterized in repeat ablations.Results: at 1 year, 77 (19.25%) patients had recurrence of af/at, significantly lower than in the mapping group: 21 (10.5%) vs.56 (28%), p < 0.001.Procedure time was shorter (72.2 ± 25.4 vs.78.2 ± 29.3 min, p = 0.034) and radiation exposure lower (4465.0 ± 3454.6 gy.Cm2 vs.5940.5 ± 4290.5 gy.Cm2, p = 0.037).Use of mapping was protective towards af/at recurrence (hr = 0.348; 95% ci 0.210-0.579; p < 0.001), independent of persistent af type (hr = 1.723; 95% ci 1.034-2.872; p = 0.037), and la diameter (hr = 1.055; 95% ci 1.015-1.096; p = 0.006).At repeat ablation (n = 90), persistent complete pvi was seen in 14/20 (70.0%) versus 23/70 (32.9%) in the mapping and conventional group, respectively (p = 0.03).Reconnection rate of the right inferior pv was lower with mapping (10.0% vs.34,3%, p = 0.035).Conclusions: adding electroanatomical la voltage mapping to cba improves 1-year clinical outcome and lowers both procedure time and radiation exposure.At repeat, use of mapping increases complete persistent pvi mainly by improving pvi durability of the ripv.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: pentaray concomitant biosense webster devices that were used in this study: lasso, carto 3 system concomitant non-biosense webster devices that were also used in this study: ensite¿cardiac mapping system (abbott inc., st.Paul, mn, usa), 8-polar inner-lumen spiral mapping catheter (achieve¿, medtronic inc., minneapolis, mn, usa), 15-fr steerable sheath (flex cath 18 advance¿, medtronic inc., minneapolis, mn, usa), 28-mm cb (arctic front advance¿), high-density mesh mapper (bard electrophysiology, lowell, ma, usa) adverse event(s) and provided interventions possibly associated with unidentified pentaray that occurred in mapping group: qty 1: stroke (cerebrovascular accident) (recognized procedural complication) (adverse event) qty 2: (pericarditis) (recognized procedural complication) (adverse event) qty 1: transient air embolism (air embolism) (recognized procedural complication) (adverse event).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: tijskens m, abugattas jp, thoen h, strazdas a, schwagten b, wolf m, de greef y.Adding electroanatomical mapping to cryoballoon pulmonary vein isolation improves 1-year clinical outcome and durability of pulmonary vein isolation: a propensity score-matched analysis.J cardiovasc dev dis.2024 feb 6;11(2):57.Doi: 10.3390/jcdd11020057.Pmid: 38392271; pmcid: pmc10889252.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: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 19588566
• Report Number: 2029046-2024-02050
• Device Sequence Number: 3340786
• Product Code: MTD
• UDI-Device Identifier: 10846835009590
• UDI-Public: 10846835009590
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_PENTARAY NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 15-FR STEERABLE SHEATH; 28-MM CB; 8-POLAR INNER-LUMEN SPIRAL MAPPING CATHETER; ENSITE¿CARDIAC MAPPING SYSTEM; HIGH-DENSITY MESH MAPPER; UNK_CARTO 3; UNK_LASSOSTAR CATHETER
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown