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 Problems Ventricular Fibrillation (2130); Ischemic Heart Disease (2493)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a 64-year-old male patient (68kg) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered st segment elevations and ventricular fibrillation (vf) requiring a cardiac catheterization and defibrillation.After st elevation vf occurred.The procedure was discontinued, and a cardiac catheterization was performed.St values increased transiently immediately after brockenbrough.Cardiac tamponade was not observed.Cardiac catheterization was planned after the procedure, but it was decided that it would be attempted ahead of schedule on short notice.Vf occurred immediately after cardiac catheterization was performed.Defibrillation was performed and the condition resolved.Ablation was discontinued because ischemic treatment may be required.The patient fully recovered.The patient did not require extended hospitalization because of the adverse event.The physician's opinions on the relationship between the event and the product is that the coronary artery may have been partially occluded originally.Transient occlusion may have occurred due to shock during brockenbrough or cag, resulting in st elevation and vf.The patient medical history: right coronary artery (rca) partial occlusion was suspected.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was patient condition and procedure related.The generator used was a smartablate.Since the event 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

An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record evaluation was performed for the finished device 30719691l number, and no internal action 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14721938
• MDR Text Key: 295025894
• Report Number: 2029046-2022-01348
• 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,Followup
• Report Date: 07/19/2022

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: 02/09/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30719691L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 06/22/2022
• Supplement Dates FDA Received: 07/19/2022; 07/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2022
• 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 SMS 8F CATHETER.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 68 KG