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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Pseudoaneurysm (2605); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2023

Event Type  Injury  

Manufacturer Narrative

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 svt (supraventricular tachycardia) cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered vascular pseudoaneurysm, arteriovenous fistula, which required, surgical intervention and prolonged hospitalization.It was reported that the patient experienced a false anevrism at right femoral puncture point and dermo-hyperdermitis (ae1).Per the study investigator, the severity was moderate, the adverse event is serious due to in-patient or prolonged hospitalization.Admission (b)(6) 2023 and discharge (b)(6) 2023.This event is not related to the study device.On (b)(6) 2023, it was reported that there is a causal relationship to the index study procedure.Intervention of surgery was provided for false anevrism and the fistula.Also the adverse event is expected/anticipated, and the outcome is recovered/resolved.This event is regarding clinical: (b)(4).

Manufacturer Narrative

Additional information was received on 17-mar-2023.Updates to false anevrism at femoral punction area and dermo-hyperdermitis (ae1): medication value "no" has been changed to "yes".It was also reported that on the same event date of 28-jan-2023, the patient experienced arterio-venous fistula at puncture point (ae2).This adverse event was already noted within the intervention field for ae1.The severity was moderate, the adverse event is serious due to in-patient or prolonged hospitalization.Admission (b)(6)2023 and discharge (b)(6)2023.Pi indicates this event is not related to the study device and causal relationship to the index study procedure.The adverse event is expected/anticipated, and the outcome is recovered/resolved with end date of (b)(6)2023.Intervention of surgery provided on the (b)(6)2023 for false anevrism and the fistula.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

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) was performed for the finished device number lot 30939908l and no internal action related to the complaint was found during the review.Based on the mre, the d4.Expiration date and h4.Device manufacture date have been updated.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

A re-review of the clinical database reveals the adverse events false anevrism at right femoral puncture point (ae1) and arterio-venous fistula at puncture point (ae2) occurring at the femoral puncture site (venous access site).These adverse events are associated with the use of a sheath for venous access.Clinical database device logs indicate the sheath was a non-biosense webster sheath.Therefore, the documented adverse events for the subject does not meet the criteria for reporting to the us fda.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: 16576857
• MDR Text Key: 311659977
• Report Number: 2029046-2023-00582
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• 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: 30939908L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 94 KG