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 Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 05/15/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced hypotension and bradycardia.It was reported that post-procedure, the patient had a significant drop in blood pressure.They reported that there were no catheters present in the body when the drop in blood pressure occurred.The medical intervention provided was drugs administered to increase the patient's blood pressure and chest compressions performed on the patient to ensure the medication would be administered throughout the body and to help sustain higher blood pressure.The patient was reported to be in stable condition.The ablation catheter was unavailable for return.The ablation catheter used was a thermocool® smart touch® sf bi-directional navigation catheter.The biosense webster inc.(bwi) representative was unable to confirm any other details of the catheter.The physician believed the drop in blood pressure to be due to bradycardia after the patient sustained an atrial flutter for a significant amount of time.They reported that no injury was confirmed besides the drop in blood pressure.The patient fully recovered (no residual effects).The patient was an inpatient consult and remained hospitalized for the initial reasons which were not directly related to the ablation.Generator information was smartablate, g4c-4551-a.

Manufacturer Narrative

Since no device has been received for analysis, 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).

• 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: 17108551
• MDR Text Key: 317055542
• Report Number: 2029046-2023-01269
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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
• Date Manufacturer Received: 05/15/2023
• 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: SMARTABLATE GENERATOR KIT-US
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male