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

Model Number	D131802
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	11/20/2019
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.No code available was used section to represent surgical intervention.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 male patient underwent a non-ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool sf nav (sf) catheter and suffered a cardiac tamponade which required pericardiocentesis and surgical intervention.The procedure was for monomorphic premature ventricular contractions (pvc) in the right ventricular outflow tract.A local activation time map was created.After defining the earliest location of the pvc, ablation was started.Ablation was performed with 30w, then with 40w.After the ablation was stopped by the physician, he noticed a drop in the blood pressure of the patient.Immediately, an ultrasound was performed, and a cardiac tamponade was noted.The electrophysiological procedure was stopped to stabilize the patient.Pericardiocentesis was performed and sternotomy.Patient was transferred to the intensive care unit and required extended hospitalization.The exact time of injury is unknown.However it is believed to have either happened during the mapping or ablation phase.No transseptal puncture was performed.The catheter was used according to the instructions for use.Generator settings were set for impedance cutoff at 250 ohms, temperature cutoff 90°c, pre radiofrequency (rf) time 1s, post radio frequency time 3s, flow rate during ablation 30 ml/min when greater than 30w.Manual ablation points were used.No error messages observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
It was reported that a male patient underwent a non-ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool sf nav (sf) catheter and suffered a cardiac tamponade which required pericardiocentesis and surgical intervention.The biosense webster inc.Product analysis lab received the device for evaluation.The investigational analysis completed 1/20/2020.The device was visually inspected and it was found in good conditions.The magnetic, temperature, and force features were tested.No issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.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
During an internal review on (b)(6) 2020, it was noticed that the manufacture date and expiration date were omitted in error.Section d4 expiration date has been updated with (b)(6) 2022 and section h4 manufacture date has been updated with (b)(6) 2019.Manufacture reference no: (b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9492341
• Report Number: 2029046-2019-04026
• Device Sequence Number: 1942591
• Product Code: LPB
• UDI-Device Identifier: 10846835009262
• UDI-Public: 10846835009262
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030031/S034
• 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,Followup,Followup
• Report Date (Section B): 01/10/2020

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: 07/07/2022
• Device Model Number: D131802
• Device Catalogue Number: D131802
• Device Lot Number: 30253630L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 05/05/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/04/2020; 05/10/2020
• 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