MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139505

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The device has been reported as discarded, 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 # 2029046-2023-02643 for product code d139505 (qdot micro).(2) mfr # 2029046-2023-02371 for product code d160902 (octaray mapping catheter).Manufacturer's reference number: (b)(4).

Event Description

Initially this event was assessed as mdr reportable under the octaray mapping catheter and submitted under manufacturer report number 2029046-2023-02371 / manufacturer's reference number (b)(4).Additional information was received on 19-oct-2023 providing the ablation catheter of qdot micro / d139505.This new information was reviewed and it was assessed that this event is now also mdr reportable under this ablation catheter.The awareness date for this record is 19-oct-2023.It was reported a patient underwent a cardiac ablation procedure which included the use of a octaray mapping catheter and the qdot micro catheter and experienced a stroke.The physician reports he performed a pulmonary vein isolation (pvi) in the morning weeks ago on a patient and later in the day the patient had a stroke.Physician cannot know if it was related to the pvi procedure or not, or related to the use of octaray mapping catheter or not.Physician is a recent user of the octaray mapping catheter and in the past years has used the pentaray catheter.Additional information was received on 19-oct-2023.The event date is 13-sep-2023.The event happened days after the procedure / days after use of bwi products.Patient has improved.The patient required extended hospitalization, the patient was hospitalized after the stroke and then had to have physiotherapy due to problems walking/moving before being sent home again after several weeks.Physician¿s opinion on the cause of this adverse event was the patient condition/comorbidities.Other relevant past medical history includes parkinson's disease, previous stroke, previous myocardial infarction, previous bypass operation.No char was evident during the procedure.No evidence of blood thrombus / clot during the procedure.

Manufacturer Narrative

Additional information was received on 06-dec-2023.The stroke occurred 2 days after ablation.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: QDOT MICRO
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18137073
• MDR Text Key: 328110493
• Report Number: 2029046-2023-02643
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P210027
• 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,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• 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: NGEN RF GENERATOR; OCTA,LNG,48P,2-5-2-5-2,D-CURVE; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 125 KG