MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number D132700

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Stenosis (2263)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the patient suffered pulmonary vein stenosis, mediastinal hematoma requiring prolonged hospitalization.Three (3) months after ablation of af by isolation of the pulmonary veins with a thermocool® smart touch¿ bi-directional navigation catheter, the patient was reviewed in a consultation and determined the patient had a persistent dry cough.The patient had a computed tomography (ct) scan showing mediastinal hematoma and probable stenosis of the left lower pulmonary vein.There was no post-op device malfunction.Additional information was later received indicating the afib ablation was in march, the adverse event was diagnosed on may 31st.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The patient outcome of the adverse event is unchanged.The patient is going to be hospitalized for an endovascular procedure.

Manufacturer Narrative

Device investigation details: available 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 a recognized lot number was not provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Initial reporter phone: (b)(6).Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14997617
• MDR Text Key: 295770399
• Report Number: 2029046-2022-01593
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2022

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: D132700
• Device Lot Number: 17230117103069807L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-WW
• Patient Outcome(s): Hospitalization