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

Model Number D134703

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pneumothorax (2012)

Event Date 03/15/2022

Event Type  Death  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) year-old female patient underwent an atrial fibrillation (afib) with a thermocool® smart touch® sf uni-directional navigation catheter and there was complications after the case with bleeding, pneumothorax and the patient died.After the case there was blood in the patient¿s lung.The patient went to surgery and had the internal jugular repaired and the lung was tapped.It is suspected when the initial stick of the internal jugular (ij) caused the issue (ij was used for cs catheter placement).They are thinking maybe a perforated ij access point that bled through the superior vena cava (svc).Access sites were at both ij and groin.The blood pressure drop was noticed at the beginning of the case as well as a ¿weird looking lung¿ while getting access/shortly after getting access.According to the nurse practitioner, several teams of doctors have analyzed the patient and none can come up with a reason why this happened.They are speculating that it was a spontaneous hemothorax which led to a pneumothorax and collapsed lung.The nurse practitioner reassured there was nothing caused from the bwi equipment or ablation as there was no bleeding from the heart or anything wrong with the heart.The patient required extended hospitalization because of the adverse event as they were taken to the intensive care unit (icu) after tapping and draining the lung.Essentially, they are thinking the spontaneous pneumothorax and collapsed lung led to patient¿s death.The date of death was (b)(6) 2022.It was also reported that the ultrasound image on the us and the carto 3 system was poor.The catheter was not replaced.The customer¿s reported poor image/catheter visualization issue is not an mdr reportable issue since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.

Manufacturer Narrative

On 15-apr-2022, additional information was received indicating the autopsy reported noted ¿8th intercostal artery ruptured¿; no further information given.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 UNI-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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14050073
• MDR Text Key: 288849118
• Report Number: 2029046-2022-00755
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134703
• Device Catalogue Number: D134703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• 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: CARTO 3 SYSTEM.; DEF 7F,20P,DOME,DUO-DECAPOLAR.; SMARTABLATE GENERATOR KIT-US.; SMARTABLATE PUMP KIT-US.; SOUNDSTAR ECO SMS 10F CATHETER.
• Patient Outcome(s): Hospitalization; Death; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female