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 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has three reports:.For product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2023-03097 for product code d142901 (optrell mapping catheter).(3) mfr # 2029046-2023-03098 for product code d138503 (carto vizigo¿ 8.5f bi-directional guiding sheath - large).

Event Description

It was reported a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, a optrell mapping catheter with trueref technology and a carto vizigo¿ 8.5f bi-directional guiding sheath - large and the patient experienced cardiac tamponade requiring a pericardiocentesis.Transseptal puncture was performed.Then during optrell mapping, about 2 hours after the start of the procedure, cardiac motion became slow and tamponade was confirmed.About 70 cc of drainage was taken, and then heart movement returned, and the patient returned to the ward.After the procedure, bleeding from the tamponade area subsided.The procedure was completed.Ablation was not performed before pericardial effusion or tamponade was identified.Steam pop was not observed.The physician's opinions on the relationship between the event and the product were, one possibility was that the right ventricle(rv) catheter that was placed during pulmonary angiogram (pa) was in the back of the right ventricle.Another possibility was considered in two patterns because pulmonary angiogram the contact force (cf) was temporarily elevated when the combination of the carto vizigo¿ 8.5f bi-directional guiding sheath - large and thermocool® smart touch® sf bi-directional navigation catheter was inserted into the lv (left ventricle).No abnormalities observed during use of the product.Patient fully recovered.

• 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: 18406670
• MDR Text Key: 331475410
• Report Number: 2029046-2023-03096
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2023

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 Catalogue Number: D134805
• Device Lot Number: 31079948L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2023
• 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: 8.5F SHEATH WITH CURVE VIZ LGC; JPN CARTO 3 SYSTEM; OPTRELL, 36 ELECTRODES, D-F; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER; SOUNDSTAR ECO GE 8F CATHETER; UNK_SMARTABLATE PUMP
• Patient Outcome(s): Life Threatening; Required Intervention