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

Model Number D134805

Device Problems Display or Visual Feedback Problem (1184); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30700872l and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.On septal puncture, it was confirmed that sl0 was inserted to the left atrium (la) on echography.Then, agilis was inserted to la under fluoroscopy.After sound map was completed, zeroing was attempted to be performed after stsf was inserted into agilis, but contact was always high.In addition, when the stsf was advanced to the posterior wall, it was deviated greatly from the merged ct.The physician thought it was questionable, so the agilis was removed once, and reinserted to the la.After the reinsertion, cf appeared properly, and there was no difference from ct.At this point, blood pressure had dropped to the 70s, so noradrenaline was given to keep blood pressure above 100.Since no pericardial fluid was observed by echocardiography, the procedure was continued.After pulmonary vein isolation (pvi) was completed, noradrenaline administration was stopped, and blood pressure decreased.Echocardiography was performed and the physician judged that there was no pericardial effusion.When the patient was checked by transthoracic echocardiography just in case, it was found that pericardial effusion had accumulated, and drainage was performed immediately.The postoperative transthoracic echocardiography revealed cardiac tamponade.After the procedure was completed, pericardial drainage was performed, and percutaneous cardiopulmonary support (pcps) was inserted.Septal puncture was performed with using rf needle.Ablation was performed before pericardial effusion or tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow setting was low:2ml/min and high:8-15ml/min, pre:1s, post:1s.Pcps was inserted due to decreased blood pressure.The complaint product(s) will not be returned for analysis.After the procedure, pericardial drainage and pcps insertion were performed, the patient returned to the icu.Blood pressure was stable, and the condition was stable.Pcps was managed with a support just in case.The physician commented that the cause may be that the agilis got into a wrong place after septal puncture.This event will be conservatively reported as ablation took place before the effusion was noticed, therefore, bwi devices cannot be excluded.Since the event (cardiac tamponade) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The visualization issue was assessed as not mdr reportable.The device is not visualized by the carto system.The user will have to replace the catheter in order to complete the case.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.The force high issue was assessed as not mdr reportable.The issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.

Manufacturer Narrative

Additional information was received on 17-may-2022.It was reported that the patient is a 70-year-old, male patient (64kg).It was also reported that the physician¿s opinion on the cause of this adverse event was that it was procedure related.The patient outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event.No relevant medical history.Therefore, h 6.Health effect - impact code was updated.The physician¿s name full name was provided as dr.(b)(6).Therefore, e 1.Initial reporter first name and e 1.Initial reporter last name were updated.The generator used was a smartablate with unknown serial number.Therefore, the concomitant product section was updated.Force visualization features were dashboard; vector; visitag with fot and tag index.The setting was stsf of the generator.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.Irrigation rate was controlled correctly.Parameters for stability were 3mm/3s/3g-25%/2mm.The lesion was atrial fibrillation (afib), not atrial tachycardia (at).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14423569
• MDR Text Key: 292164738
• Report Number: 2029046-2022-01038
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

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 Expiration Date: 01/05/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30700872L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2022
• 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: SOUNDSTAR ECO GE 8F CATHETER; UNK AGILIS; UNK RADIOFREQUENCY (RF) NEEDLE; UNK SL0; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 64 KG