MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D132701

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 11/19/2021

Event Type  Injury  

Manufacturer Narrative

Literature article cannot be attached as the electronic file size is too large.This complaint is from a literature source.The following literature cite has been reviewed: osawa t, mori h, kawai a, kawano d, tsutsui k, ikeda y, yamaga m, sato a, gatate y, hamabe a, tabata h, kato r, matsumoto k.Effects of uninterrupted dabigatran on the intensity of anticoagulation during atrial fibrillation ablation.J arrhythm.2021 nov 19;38(1):58-66.Doi: 10.1002/joa3.12655.Pmid: 35222751; pmcid: pmc8851590.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).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: osawa t, mori h, kawai a, kawano d, tsutsui k, ikeda y, yamaga m, sato a, gatate y, hamabe a, tabata h, kato r, matsumoto k.Effects of uninterrupted dabigatran on the intensity of anticoagulation during atrial fibrillation ablation.J arrhythm.2021 nov 19;38(1):58-66.Doi: 10.1002/joa3.12655.Pmid: 35222751; pmcid: pmc8851590.Abstract: background: uninterrupted dabigatran during atrial fibrillation (af) ablation is now established as the standard therapy.However, there are few reports on the effects of uninterrupted dabigatran on the intensity of anticoagulation during af ablation.Methods: authors retrospectively analyzed 247 consecutive patients who underwent af ablation in our hospital from january 2017 to december 2018.Patients who took warfarin or uninterrupted direct oral anticoagulants (doacs) except for dabigatran were excluded.89 patients underwent ablation with uninterrupted dabigatran (uninterrupted group, male 71, mean age 59.6 ± 14.0) and 124 with interrupted doacs (interrupted group, male 105, mean age 56.9 ± 12.9) during af ablation.The initial act level, proportion of act levels of more than 300 s, and total amount of heparin were compared.Furthermore, the incidence of procedure complications was also evaluated.Results: the initial act levels were significantly higher in the uninterrupted group, and the total number of acts of more than 300 s was significantly higher in the uninterrupted group (uninterrupted vs.Interrupted; initial act level, 315.6 ± 59.8 vs.264.5 ± 48.6, p <.001; total number of acts ¿300, n [%], 304/ 484 [62.8 %] vs.372/745 [49.9%], p <.001).The total amount of heparin during procedure was significantly lower in the uninterrupted group (uninterrupted group vs.Interrupted group; 12966 ± 4773 vs.16371 ± 5212, p <.001).There was no significant difference in the incidence of complications between the two groups.Conclusions: in the catheter ablation of af, uninterrupted dabigatran would be useful to obtain a stable anticoagulation status during the entire procedure.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 system , penta ray mapping catheter.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with biosense webster suspected device: qty 1 cardiac tamponade treated with pericardiocentesis.Qty 3 pericardial effusion - no interventions reported.Qty 1 gastrointestinal hemorrhage (no blood transfusion was needed).Qty 1 thromboembolic resulting in transient ischemic attack (brain computed tomography showed no evidence of bleeding.Magnetic resonance imaging excluded acute cerebral infarction).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 16457580
• MDR Text Key: 310409634
• Report Number: 2029046-2023-00407
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2023

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 Model Number: D132701
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/28/2023
• 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: CARTO 3 SYSTEM; PENTA RAY MAPPING CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening