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

Catalog Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 09/14/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure using a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced an aortic dissection that required surgical repair.All the ablation catheter signals were noisy on both the carto and recording system.The physician had intact ecg signal available to monitor the patient¿s heart rhythm.The catheter was replaced but the noise remained on the distal signals.The cable was then replaced which resolved the remaining noise.Later in the procedure, during retrograde access in preparation for radio frequency delivery, the second ablation catheter was repeatedly caught in a dissection in the aortic arch.This occurred during the advancement in the descending aorta, dissection was discovered, they were unable to further advance the catheter into the lv (left ventricle).No ablation was performed.The physician thought the dissection was pre-existing but that the ablation catheter may have made it worse.Mapping was first performed with a pentaray catheter without any issues on insertion to the left ventricle.The procedure was aborted due to inability to maneuver the catheter to the left ventricle to ablate.The patient is currently stable.The physician's opinion on the cause of this adverse event was the patient's condition.Procedure was aborted and patient transferred to a different facility for surgery.The patient will need a dissection repair.The patient required extended hospitalization because of the adverse event.The noise issue was assessed as non mdr reportable.The adverse event was assessed as a mdr reportable serious injury adverse event.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 reference number: (b)(4).

Manufacturer Narrative

The investigation was completed on 01-nov-2023.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31119651l number, and no internal actions related to the complaint was found during the review.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: 17913615
• MDR Text Key: 325407257
• Report Number: 2029046-2023-02284
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31119651L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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: BUNDLE-CABLE-CR3434CT-000139.; SMARTABLATE GENERATOR KIT-US.; THMCL SMTCH SF BID, TC, D-F.; UNK RECORDING SYSTEM.; UNK_CARTO 3.; UNK_PENTARAY.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female