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 Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Pneumothorax (2012); Ventricular Fibrillation (2130)

Event Date 12/06/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6)-year-old male patient ((b)(6), 164cm) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered ventricular fibrillation, cardiac arrest, hemopneumothorax with chest tube drainage and bleeding.Although blood pressure was low at the end of the procedure, it was assumed to be due to stimulation of hemostasis and the patient returned to the ward.However, blood pressure did not increase after returning to the ward, and the patient¿s physical condition worsened at night.The patient developed ventricular fibrillation (vf) due to hemopneumothorax/hemorrhagic shock, and resuscitation was performed for about one hour including cardiac massage.Drainage was also performed, and the patient was intubated before dawn.The patient remained intubated at the time of the call and was being followed up on.The physician commented that there was no involvement of biosense webster product because of the problem at the time of puncture, not ablation.No abnormalities were observed before/during product use.Additional information was received on 16-dec-2021.It was reported that the physician¿s opinion on the cause of this adverse event is that this is procedure related.The patient outcome of the adverse event was reported as unchanged.Prior to noting the adverse event, ablation was performed.There was no evidence of a steam pop.No error messages were observed on the biosense webster equipment during the procedure.Conservatively, this was assessed as mdr reportable as ablation was performed.Should additional information become available, this will be reassessed accordingly.

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore 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 reference number: (b)(4).

Manufacturer Narrative

A manufacturing record evaluation (mre) was performed for the finished device 30633727l number, and no internal actions related to the complaint was found during the review.Based on the mre, the d4.Expiration date and h4.Device manufacture date have been updated.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13122855
• MDR Text Key: 288275141
• Report Number: 2029046-2021-02283
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30633727L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG