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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6) year-old male patient, weighing 70.0kg, with height of 168.00 cms.Underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring a pericardiocentesis.After the completion of the procedure, blood pressure rapidly decreased.Cardiac tamponade was confirmed by echocardiography.The adverse event was discovered post use of biosense webster products.Pericardial drainage was conducted.The patient was followed up after conducting drainage.Relevant tests/laboratory data---no data.Other relevant history---no relevant history.Transseptal puncture was performed with rf needle.Ablation was performed prior to noting the ct.There was no evidence of a steam pop.The event occurred after the ablation procedure was completed.No error message was observed during the ablation procedure.Force visualization features used were real time graph, dashboard, vector and visitag.Color option used prospectively was tag index.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Transseptal puncture took longer than usual and was performed for more than 1 hour.The physician commented that the possibility of cardiac tamponade due to cavotricuspid isthmus (cti) ablation could not be ruled out because the physician was switched to a younger physician at the time of cti ablation.Pericardial drainage was conducted.Outcome of the adverse event was improved.It was also reported that a 116 sensor error, and poor display of pentaray occurred.The event occurred before initiation of la-mapping after left atrial approach.Two consecutive's defective pentaray were found.The first one was 116 sensor error.The second one was defective display of pentaray.Spine did not appear, and only the shaft was turned around and the display was defective.The cable replacement, indifferent electrode (patch), and patch connection were confirmed, but the issue was not resolved.Therefore, the catheter was replaced, and the issue was resolved.The procedure was successfully completed.The magnetic sensor error is not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death is remote.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.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Section h3.Has been updated.A manufacturing record evaluation (mre) was performed for the finished device and no internal action related to the complaint was found during the review.Based on the mre, the h4.Device manufacture date has been updated.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15955898
• MDR Text Key: 305241001
• Report Number: 2029046-2022-03084
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30886537L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; UNK BRAND CATHETER; UNK RADIOFREQUENCY NEEDLE; UNK_CARTO 3; UNK_PENTARAY NAV; UNK_PENTARAY NAV
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG