MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCFH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.On 7/9/2019, a manufacturing record evaluation was performed and no internal actions were found during the review.The event date is unknown.As such, the 1st day of the alert month has been entered as the event date ((b)(6) 2019).The corresponding field of this report has been updated.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient with history of implantable cardioverter defibrillators (icd) implantation due to ventricular tachycardia (vt) and cardiopulmonary resuscitation (cpr), underwent an epicardial/endocardial procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.The physician first performed the epicardial puncture.The physician then punctured the groin for placement of both endocardial right ventricle rv catheter and an ablation catheters.The rv catheter was placed through a short 7fr sheath and into the rv.The ablation catheter was placed in the femoral artery through an 8 fr long (arrow) sheath.Mapping was performed in the aorta and in the left ventricle (lv).Mapping was performed to the earliest activation point and ablation was completed.The arrhythmia then stopped.There was a waiting period and after 20 minutes after the start of the procedure, the physician noticed a substantial amount of medium-dark blood coming from the epicardial site.The patient¿s blood pressure declined, and cardiac tamponade was confirmed.Pericardiocentesis was performed to remove 3 liters of blood from the pericardial space.The patient underwent surgical intervention to find the leak and repair the perforation.After surgery, it was determined that the event occurred due to epicardial puncture into the left ventricle.The surgery was fast, and the patient was discharged to intensive care.Extended hospitalization was required as a result of the adverse event.Patient¿s outcome was improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Transseptal puncture was not performed.The ablation settings were set at power control of 45 watts, with temperature settings with a warning at 40c and cut-off of 43c.Impedance max cut-off was 290 ohms, spike off, minimum cut-off 50 ohms.The flow was set for 2ml/min while mapping and 20ml/min while ablating.During the ablation, there was one application for a total time of 30 seconds.The maximum temperature was 38c, average 34c, and minimum 32c.Impedance maximum was 125 ohms, average 98 ohms, and minimum 84 ohms.Total energy delivered was 1319 joules with total irrigation of 288ml.No error messages were observed on any biosense webster inc.(bwi) equipment during the procedure.The activated clotting time (act) was between 300-350 seconds.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8789718
• Report Number: 2029046-2019-03404
• Device Sequence Number: 2014525
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30178583M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 100