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 Problem Bradycardia (1751)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).Requested clarification as the complaint did not reflect a death; however, the date of death field was filled out as (b)(6) 2023.However, no further information has been made available on this discrepancy.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 was performed for the finished device 30985804l number, and no internal action related to the complaint was found during the review.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional catheter.The patient experienced bradycardia requiring intervention.It was reported that after defibrillation in af case to sinus rhythm, patient became bradycardic.Sat and blood pressure decreased.Cardiac massage did not recover the patient's condition, and the patient was stabilized by ecmo (extracorporeal membrane oxygenation) insertion.The patient was returned to the icu (intensive care unit).Timing was after inserting the catheter into the patient's body.Description of health problem was bradycardic.Physician's judgment on health hazard was serious.Extended hospitalization was required.Causal relationship with product was unknown.The physician's opinions on the relationship between the event and the product was that there was no causal relationship between event and product.There were no abnormalities observed prior to and during use of the product.The procedure was completed without patient's consequence.Additional information was received.The adverse event was discovered during use of biosense webster products.Intervention provided was cardiac massage and ecmo.The patient required extended hospitalization for ecmo insertion.Additional information: physician¿s opinion on the cause of this adverse event is patient condition.The patient¿s ef (ejection fraction) was very low prior to the procedure.No causal relationship between event and the product.Reporter clarifies that "cardiac massage" is cardiopulmonary resuscitation performed on the patient's body surface (cpr).Outcome of the adverse event is patient has improved.The patient has been withdrawn from the ecmo.Medical history: atrial fibrillation.

Manufacturer Narrative

In the 3500a initial it was stated that a clarification was requested as the complaint did not reflect a death; however, the date of death field was filled out as (b)(6) 2023.However, no further information had been made available on this discrepancy.Additional information was received on 18-may-2023 clarifying that the field ¿death¿ was filled out by mistake.They did not receive information indicating the patient death.Therefore, a request was made to remove the ¿date of death¿.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16943690
• MDR Text Key: 315354648
• Report Number: 2029046-2023-01046
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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
• Device Lot Number: 30985804L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male