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

Catalog Number	NI75TCJH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.Upon initial inspection, no visual damage or anomalies observed.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a 73-year-old male patient with history of 3 previous ablation procedures, underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase, the patient became hypotensive and the physician heard a steam pop.At this time, there was a sudden impedance spike/drop.Cardiac tamponade was confirmed by ultrasound.Pericardiocentesis was performed to remove 800 cc of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.The patient was then transferred to the intensive care unit.Extended hospitalization was required, for monitoring purposes.The patient¿s outcome was fully recovered.Physician¿s opinion regarding the cause of the adverse event is that it occurred due to the steam pop experienced.Transseptal puncture was performed with baylis nrg transseptal needle, standard curve c0 (catalog/ref nrg-e-hf-71-c0).The flow was set at 30 ml/min.No error messages were observed on any biosense webster inc.Equipment during the procedure.The parameters for stability used with the visitag module were range 3mm, time 5sec, 2mm tag size.The color option used prospectively was time, 5-20 sec on coloring for tags & grid.
Additional Manufacturer Narrative
It was reported that a 73-year-old male patient with history of 3 previous ablation procedures, underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase, the patient became hypotensive and the physician heard a steam pop.At this time, there was a sudden impedance spike/drop.The investigational analysis completed on 8/29/2019.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized, with no errors were observed.Electrical testing was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Irrigation and deflection testing was performed and it was found within specifications.The catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed and no internal actions were identified.  the catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacture reference no: (b)(4).
Additional Manufacturer Narrative
It was reported that a 73-year-old male patient with history of 3 previous ablation procedures, underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.Additional information was received on(b)(6)2019 , indicating the operator was unable to use the stop button and instead used the used the foot pedal for ablation.The impedance cut-off (250 ohms) was not exceeded and impedance was not above cut-off value.Generator parameters were set to: power control mode; temperature cut off at 42 degrees, impedance max cut off at 250 ohms, spike cut off at 75 ohms, min cut off at 50 ohms, and power cut off at 43w.The noted temperature, impedance, and power were set at at 43w for power, temperature between 20-22 degrees, and impedance between 98-102 ohms.Smartablate generator kit serial (b)(4).Was used during the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

• 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: 8928746
• Report Number: 2029046-2019-03571
• Device Sequence Number: 268753
• Product Code: OAD
• UDI-Device Identifier: 10846835000573
• UDI-Public: 10846835000573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2019

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: 10/18/2021
• Device Catalogue Number: NI75TCJH
• Device Lot Number: 30144133M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 08/28/2019; 08/29/2019
• Initial Report FDA Received Date: 08/25/2019
• Supplement Report FDA Received Date: 09/23/2019; 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAYLIS NRG TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 101