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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device (and packaging) 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 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) male underwent an atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac arrest and respiratory arrest requiring cardiopulmonary resuscitation (cpr) and ventilation.After the case was completed and the patient was still on the table, the patient began having trouble breathing and coded.The anesthesia monitoring and the carto® 3 patches were still connected.The patient was provided chest compressions and was reintubated.The patient was moved to the intensive care unit and was in stable condition.The physician¿s opinion on the cause of this adverse event is that the physician believes the root of the adverse event was related to anesthesia and unrelated to the use of bwi products.The adverse event was discovered post use of biosense webster products.The patient required reintubation and mechanical ventilation as intervention.The patient condition is unknown at this time, however, the patient left the electrophysiology (ep) lab in stable condition.It is unknown if the patient required extended hospitalization because of the adverse event.

Manufacturer Narrative

Manufacturer's ref # (b)(4) during an internal review of this event, it was determined that this event should not have been assessed as mdr reportable against any bwi products.The bwi products are concomitant in the event since the physician reported the patient adverse event was anesthesia-related.As such, this event has been reassessed and will no longer be considered mdr reportable event.

• 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: 12704306
• MDR Text Key: 278564519
• Report Number: 2029046-2021-01828
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/18/2022

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 Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 01/18/2022
• 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; CARTO3 EXTERNAL REFPATCH 6PACK; UNKNOWN ANESTHESIA MONITOR; UNK_SMART TOUCH BIDIRECTIONAL SF; CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; UNKNOWN ANESTHESIA MONITOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male