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

Catalog Number D132705

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the patient experienced pulmonary vein stenosis.Stenosis at left inferior pulmonary vein (lipv) had occurred for the patient who underwent the afib procedure on (b)(6) 2023.Patient's condition was stable.The data was checked in review and there was no problem with the vector orientation.It was confirmed that the contact force (cf) that the ablation occurred at was 'somewhat strongly' at 30g and a company representative informed the physician of this.No abnormalities were observed prior to or during use of the product.No information regarding what treatment was provided to the patient if any were provided.At this time, the event is being reported on the ablation catheter as a conservative measure until it is confirmed that a treatment was not required for the stenosis.

Manufacturer Narrative

On 1-mar-2024, bwi received additional information regarding the event.Patient has improved.Physician's opinion on the cause of the event was the procedure.Might have too much ablated inside of the left inferior pulmonary vein (lipv).The physician details were updated in section e as well as their identity has been made available.Additionally, the product investigation has been completed since the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 18758537
• MDR Text Key: 336002443
• Report Number: 2029046-2024-00586
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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: SOUNDSTAR ECO SMS 8F CATHETER.; UNK_CARTO 3.
• Patient Outcome(s): Other
• Patient Sex: Male