MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTA,LNG,48P,3-3-3-3-3,F-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D160906

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

The lot number reported was 31135346; however, it is not a recognized number.Therefore, multiple attempts have been made to obtain clarification.However, no further information has been made available.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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00139 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2024-00141 for product code d160906 (octaray mapping catheter).

Event Description

During a clinical trial, it was reported that a patient underwent an atrial fibrillation (afib) procedure with an octaray mapping catheter and a thermocool® smart touch® sf bi-directional navigation catheter and experienced a pericardial effusion which required prolonged hospitalization.A patient received an index cardiac ablation for afib on (b)(6) 2023.On (b)(6) 2023, patient experienced a pericardial effusion categorized as moderate and serious defined by serious deterioration in health of the subject due to in-patient or prolonged hospitalization with admission date of (b)(6) 2023 and discharged (b)(6) 2023.Relationship to study device is possible to study devices thermocool® smart touch® sf bi-directional navigation catheter and an octaray mapping catheter, and relationship to primary study procedure is probably to the index procedure.The serious event is categorized as expected/anticipated.The outcome is unknown.Medication was administered for intervention.Bmi: 30.0 kg/m2.

Manufacturer Narrative

In the 3500a initial, it was reported that the relationship to the primary study procedure is probably to the index procedure and the outcome is unknown.Additional information was received on (b)(6) 2024 stating the relationship to primary study procedure is possible to the index procedure and the outcome is recovering / resolving.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 10-jan-2024, providing the concomitant product of the non bwi-agilis sheath.Therefore, added to the "d10.Concomitant medical products and therapy dates" field.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: OCTA,LNG,48P,3-3-3-3-3,F-CURVE
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 18489446
• MDR Text Key: 332602720
• Report Number: 2029046-2024-00141
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: 10846835021134
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D160906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NON BWI-AGILIS SHEATH; THMCL SMTCH SF BID, TC, D-F; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 93 KG