MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NR7TCSIY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: available information indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30740341m 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 4.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 (b)(6) year-old male patient ((b)(6) kg) underwent a cardiac ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis, surgical intervention and prolonged hospitalization.The cardiac tamponade was noticed right after procedure.The procedure has been successfully completed.The patient required surgery for the cardiac tamponade.The physician¿s opinion on the cause of this adverse event is that it was procedure related.Draining from epicardial space was also performed.The patient outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event.Activated clotting time (act) range was 257-306 during the procedure.Heparin 12000 iu after transseptal, total 23000 iu during procedure.A smartablate generator was used during this case.A transseptal puncture was performed with an abbott brk-1, 407201.There was no evidence of steam pop.The irrigated catheter flow setting was set to 2/17 ml.The correct catheter settings were selected on the smartablate generator and the pump switching from low to high flow during ablation.

Manufacturer Narrative

On 8-jul-2022, additional information was received which indicated pericardium puncture was performed to drain the pericardial space; no open-heart surgery.Based on this new information, please consider the 6.Health effect - impact code of ¿surgical interventions¿ (f19) to be removed.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: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; 646591-798
• MDR Report Key: 14684195
• MDR Text Key: 294922035
• Report Number: 2029046-2022-01292
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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 Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30740341M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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: ABBOTT BRK-1; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; SOUNDSTAR ECO GE 8F CATHETER; UNKNOWN PUMP
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 120 KG