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 12/10/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered hypotension and bradycardia resulting in surgical intervention.It was reported that after pulmonary vein isolation (pvi) was completed, and after several points on the superior vena cava (svc) were ablated, the patient¿s heart rate decreased from 50 to 30, and blood pressure decreased to 50.There was no pericardial effusion.There was no notable change in impedance.The procedure was completed using beat hra pacing to supplement and support the patient's own pulse.Improvement of bradycardia was also attempted with atropine sulfate hydrate, but no improvement was obtained after 30 minutes.As pacemaker placement was also reported at mund therapie, the patient was transferred from the catheter room to the treatment room and disinfected, and then recovered.The course was uneventful without pacemaker implantation.The course was uneventful.The physician commented that the cause was determined to be that the site of svc ablation was close to right atrial (ra) ganglionated plexi (gp) (autonomic nerve).There was no sense of incongruity during use of the product, and it was declared that it was not derived from the product.

Manufacturer Narrative

(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 14-jan-2022 biosense webster inc.Received additional information about the patient and event.It was reported the adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of the adverse event is that it was procedure related.The patient¿s outcome from the adverse event was reported as improved after the procedure.It is unknown if the patient required extended hospitalization because of the adverse event.A transeptal puncture was likely performed because pvi was conducted before the event.No pericardia effusion or cardiac tamponade.There was no evidence of steam pop.No error messages were observed on biosense webster equipment during the procedure.A smartablate generator was used during the procedure.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device 30609932l number, and no internal actions related to the complaint was found during the review.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13217428
• MDR Text Key: 284209935
• Report Number: 2029046-2022-00069
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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 Expiration Date: 08/02/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30609932L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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): Required Intervention