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

Model Number BDI35FJRT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130); Cardiac Tamponade (2226)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient ((b)(6) lb) underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® sf bi-directional catheter and suffered cardiac tamponade (requiring pericardiocentesis) ventricular fibrillation and cardiac arrest (requiring cardiopulmonary resuscitation (cpr)).During the procedure while ablating at 50 watts in the left ventricle (lv) the physician performed a pacing protocol, the patient was hemodynamically stable; however, it was noticed that the patient¿s heart rhythm changed to ventricular tachycardia (vt), and then degraded into ventricular fibrillation (vfib).Cardiopulmonary resuscitation protocols were performed by the medical staff for about 3-4 minutes until the implantable cardioverter defibrillator (icd) was able to restore the rhythm and start pacing.There was a slow rise in the impedance when the physician was ablating in the right ventricle (rv) but there was no high force values or drastic impedance changes throughout the procedure.The physician confirmed the presence of pericardial effusion and a suspected perforation to the rv or lv apex.Cardiac tamponade was confirmed by soundstar catheter and pericardiocentesis was performed to remove about 20ml of fluid from the pericardial space.Pericardial drainage tube was left in place and the patient was admitted and transferred to the operating room (or).The patient was stable but with a significant effusion while leaving the ep lab.The patient coded again while in route to the or, and the medical staff performed cpr protocols, drained the effusion and were able to revive the patient.It is unknown if a procedure was performed in the or.Patient¿s condition improved.There¿s no information on if extended hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that the rv as perforated with the ablation catheter.Transseptal puncture was performed with a baylis transseptal needle.There was no evidence of steam pop during the ablation.The catheter flow was set at 15ml/min.The force visualization features used included graph, dashboard, vector and visitag.Visitag settings were 2.5 mm for 3 seconds at 3g of force.Time was used as color option.The max wattage used during the case was 50 watts.The total rf lesions were about 100.The total fluid drained was 2,500ml and the total procedure time was about 6 hours.No bwi product malfunction was reported.

Manufacturer Narrative

Upon internal review on 7/10/2020, it was discovered that within section e the facility name and address were mistakenly omitted from the initial report.Section e has been updated accordingly within this supplemental report.Additionally, a manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 SF BI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10248704
• MDR Text Key: 198876265
• Report Number: 2029046-2020-00827
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002843
• UDI-Public: 10846835002843
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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
• Device Operator: Health Professional
• Device Model Number: BDI35FJRT
• Device Catalogue Number: BDI35FJRT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NON BWI-BAYLIS TRANSSEPTAL NEEDLE; UNK_SOUNDSTAR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 91