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

Catalog Number D134805

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/04/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure using a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.This was a case of epicardial ablation in a procedure for vt.No defects or errors have been observed with the product used intraoperatively.Postoperatively, cardiac tamponade was observed, and pericardial drainage was performed and a drain tube was placed.The patient was returned to the intensive care unit (icu).The procedure had been completed.Transseptal puncture was not performed.Pericardial effusion or tamponade was not identified during ablation.Steam pop was not confirmed.The physician's opinion on the adverse event was possibly intercostal artery was injured.This is not an adverse event caused by a product defect.No abnormalities observed prior to or during use of the product.

Manufacturer Narrative

E1.Initial reporter address line 1 (cont.): (b)(6).E.1.Initial reporter phone: (b)(6).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 31099933l number, 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 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

On 01-nov-2023, additional information was received, and it was reported that the patient improved.Also, after internal review on 02-nov-2023, the h 6.Medical device problem code of ¿off-label use (a2304)¿ was added since the reporter mentioned contraindication with epicardial ablation.Also, in the catheter¿s instruction for use (ifu), it described directions for endocardial ablations (no mention of epicardial ablation).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: 18039199
• MDR Text Key: 326969399
• Report Number: 2029046-2023-02489
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31099933L
• 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: 07/20/2023
• 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,F,2.4MMLE,282MM,; UNK_CARTO 3.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 110 KG