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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Additional 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.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 an atrial fibrillation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and experienced a cerebrovascular accident.Adverse event was a cerebral infarction.Stroke was discovered after the procedure on (b)(6) 2023.The subsequent course was unknown.No abnormalities observed prior to use of the product.No abnormalities observed during use of the product.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 12-apr-2023.It was discovered post use of biosense webster products.No intervention was reported.Patient required extended hospitalization because of the adverse event.The generator service was not needed.Therefore, processed the following fields: d10.Concomitant medical products and therapy dates.B2.Is hospitalization initial/prolonged.H6.Health effect - impact code.In addition, the physician information was provided.Therefore, processed section e.Initial reporter.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 18-may-2023.Physician commented the cause of this adverse event could not be determined.Patient required extended hospitalization because of the adverse event but details regarding the reason for the extended hospital stay wasn¿t obtained.There was no evidence of char during the procedure or evidence of blood thrombus / clot during the procedure.Correct catheter settings were selected on the generator.Pump switching was from low to high flow during 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: 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: 16580127
• MDR Text Key: 311662019
• Report Number: 2029046-2023-00586
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 06/12/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 05/18/2023
• Supplement Dates FDA Received: 05/05/2023; 06/12/2023
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; DEF,7F,15MM DIA,CCW,20P,2X10DR; UNKNOWN BRAND GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 60 KG