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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).It was indicated 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 number lot 31228806l 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 an atrial fibrillation ablation and during the ablation phase, the patient experienced cardiac tamponade that required pericardiocentesis.They created pulmonary vein isolation (pvi) and roof line with cryo ablation.After mapping with an octaray catheter, bottom line and roof line were added.One hour after thermocool® smart touch® sf bi-directional navigation catheter use, cardiac tamponade was noted.After ablating the anterior side from the roof, blood pressure was found to be dropping.Echo showed effusion, and pericardiocentesis was performed.About 700 cc of bleeding was drained, and the blood pressure stabilized afterwards.The patient returned to the room.No abnormalities were observed prior to or during use of the product.Radiofrequency (rf) needle was used for transseptal puncture.There were no error messages observed on biosense webster equipment during the procedure.Additional information received indicated that the patient improved.Prior to noting the pericardial effusion, ablation was performed.The physician's opinion on the cause of this adverse event was that it was procedure related.The issue might have been caused by steam pops.Pop with partial ablation of the roof was confirmed.This was not caused by this product.Rf ablation was performed on bottom line and roofline.After ablating the anterior side from the roof, blood pressure was found to be dropping and the pericardial effusion was noted.

• 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: 19165794
• MDR Text Key: 340848454
• Report Number: 2029046-2024-01338
• 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
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• 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: 31228806L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2024
• 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: OCTA,STD,48P,2-2-2-2-2,D-CURVE; SOUNDSTAR ECO GE 8F CATHETER; UNK RF NEEDLE; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 60 KG