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 Heart Block (4444)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (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 31033708l 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.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).

Event Description

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a heart block av.It was reported that when the catheter was connected and inserted into the patient's body, noise occurred at 7-8 electrodes of decanav catheter.Cable was replaced but the issue continued.The issue was resolved by replacing the decanav catheter to a new one.The procedure was completed without any problem using the catheter replacement.The noise occurred intracardiac only, in both carto and lab.The catheter was inside the patient's body at the time of the noise.The first decanav catheter was related to the noise issue and was replaced with the second decanv.The second decanv catheter had no issue.It was also reported that a heart block occurred post-op.The patient was under observation.The physician¿s assessment of the health problem was that it was non-serious (moderate/minor).Methods of contact force (cf) monitoring were dashboard, vector, visitag.The coloring setting of visitag was tag index.There was no causal relationship with the product.There were no abnormalities observed prior to use of the product.The patient¿s medical history include a cardiac resynchronization therapy with defibrillator (crt-d) implanted due to cardiac dysfunction.There was no problem during the procedure because the patient was under complete ventricular pacing.Av block (2:1) was confirmed at the time of postoperative check.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Due to the pvc source being near the av node, the ablation was started from the distal side.No intervention required.The patient was implanted crtd pre procedure.2:1 block remained.The patient has full paced cardiac ventricle, so no additional intervention required.The patient did not require extended hospitalization.The noise issue is not mdr reportable.The risk to the patient is low.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.

• 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: 17239582
• MDR Text Key: 318286989
• Report Number: 2029046-2023-01436
• 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: Other
• Type of Report: Initial
• Report Date: 06/30/2023

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31033708L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; 7FR DECAN,11P,D,2.4MMLE,282MM,; SMARTABLATE GEN. KIT (JAPAN); UNK_CARTO 3
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 61 KG