MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D132704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	01/31/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Initial reporter facility name (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 or Problem Description
It was reported that a (b)(6) male patient underwent an ischemic ventricular tachycardia - left (isvt- left) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered ventricular fibrillation (vfib) requiring cpr, defibrillation, medications.The patient expired.During the procedure, the team mapped an episode of ventricular tachycardia (vt) on the left ventricle (lv) and made 3 radiofrequency (rf) applications on site of interest (within normal parameters).Before finishing last application, patient developed vfib.Physicians tried to defibrillate on many occasions and revert it with drugs, without success.After 30min of cardiopulmonary resuscitation (cpr), the patient died.There was no presence of pericardial effusion on echocardiography (echo).The procedure was not completed.Additional information received on 7-feb-2022.The date of death was (b)(6) 2022.The physician¿s opinion on the cause of death is that it is patient condition related (ventricular electrical storm (ves)).The force visualization features used were graph, dashboard, vector & visitag with the visitag module parameters for stability set to maximum distance change 3mm; minimum time 3s; force over time 25%; minimum force 3g.The additional filters used with the visitag were respiration adjustment and tag index.The generator used was a stockert st-0409 (ep shuttle sys 100w).
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 03-mar-2022.The device evaluation was completed on 22-mar-2022.It was reported that a 66-year-old male patient underwent an ischemic ventricular tachycardia - left (isvt- left) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered ventricular fibrillation (vfib) requiring cpr, defibrillation, medications.The patient expired.During the procedure, the team mapped an episode of ventricular tachycardia (vt) on the left ventricle (lv) and made 3 radiofrequency (rf) applications on site of interest (within normal parameters).Before finishing last application, patient developed vfib.Physicians tried to defibrillate on many occasions and revert it with drugs, without success.After 30min of cardiopulmonary resuscitation (cpr), the patient died.There was no presence of pericardial effusion on echocardiography (echo).The procedure was not completed.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch¿ bi-directional navigation catheter.Per the event, several tests were performed.The force, magnetic, and temperature features were tested, and no issues were observed.In addition, the product was deflecting and flushing correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the complaint were found during the review.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13610781
• Report Number: 2029046-2022-00388
• Device Sequence Number: 1957226
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30602786M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EP SHUTTLE SYS 100W; PENTARAY NAV ECO 7FR, F, 2-6-2
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR
• Patient Sex: Male