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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluation details: information received indicates that the device is not available for return, 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.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.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 61-year-old male patient underwent an afib - paroxysmal ablation procedure with a thermocool®sf nav bi-directional navigation catheter and the patient suffered cardiac arrest requiring cardiopulmonary resuscitation (cpr) and medication(s).It was reported by the bwi representative, that the lasso® catheter had a problem with the deflection mechanism, the barrel controller on the handle was loose, and the loop of the catheter would not be closed.The catheter was replaced, and the issue was resolved.The case continued.The customer¿s reported issues with the handle and the loop contraction are not considered to be mdr reportable since the device can¿t be used.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.It was also reported that after the procedure was completed and the patient was cardioverted the patient went into cardiac arrest.They stated that cpr was being done on the patient, and the patient was also being treated with other medication.The patient was no longer coding and appeared to be stabilized.The adverse event was discovered during use of biosense webster products, post afib ablation but carto 3 system was still on, and catheters were still in the body.The physician¿s opinion on the cause of this adverse event was the patient¿s condition.Physician states the adverse event was unrelated to biosense products.Additional interventions provided were unknown.The patient¿s outcome from the adverse event was reported as fully recovered.Patient was extubated within 2 hours of completion.Physician kept patient overnight as a precaution to monitor and discharged the next day.

• Brand Name: THERMOCOOL®SF NAV 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: 15939007
• MDR Text Key: 305045928
• Report Number: 2029046-2022-03055
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 11/08/2022
• 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; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE GENERATOR SPARE-US
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male