MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D160902

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported a patient underwent a cardiac ablation procedure which included the use of a octaray mapping catheter 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.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on 19-oct-2023.The event date is (b)(6) 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.Therefore, updated fields (b)(6) 2023 h6.Health effect - impact code, h6.Health effect - impact code and b2.Is hospitalization initial/prolonged was checked.The ablation catheter of qdot micro / d139505 was also provided.This event was also assessed as mdr reportable under the ablation catheter.Biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2023-02643 for product code d139505 (qdot micro).Mfr # 2029046-2023-02371 for product code d160902 (octaray mapping catheter).In addition, the patient information, physician information, concomitant products.Therefore, updated sections a.Patient information, e.Initial reporter and d10.Concomitant medical products and therapy dates.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 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: OCTARAY MAPPING CATHETER
• 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: 17962573
• MDR Text Key: 326006272
• Report Number: 2029046-2023-02371
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K193237
• 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,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D160902
• 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; QDOT MICRO, BI, TC, D-F; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 125 KG