MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	1086259RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/19/2019
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.The thermocool® smart touch® sf bi-directional navigation (stsf) catheter was initially reported in report number: 2029046-2020-00058.However, additional info was received 1/15/2020 indicating that the physician¿s opinion regarding the cause of the adverse event is that it was caused by an right ventricle (rv) webster¿ electrophysiology catheter.The initially reported stsf catheter has been updated in the concomitants section.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 female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a webster¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure while using an stsf catheter noise was observed from the catheter electrodes being displayed on the carto 3 and electrophysiology recording systems.The cable was replaced, but the issue remained.The catheter was then exchanged, and the issue was resolved.The procedure continued successfully.The carto 3 system was operating per specifications and is not considered responsible of the issue.The catheter was determined to be the root cause of the issue experienced.It was also reported that pericardial effusion was noted after transseptal access and after some ablations were done with the replacement stsf catheter.The patient¿s systolic blood pressure dropped to 90, and cardiac tamponade was confirmed by ultrasound and intracardiac echocardiography (ice).Pericardiocentesis was performed and a total of 330 cc of fluid was removed from the pericardial space.The procedure continued and some other ablations were done.However, the procedure was unable to be completed due to the proximity of the conduction system to the area of ablation.No ablation was done prior to the effusion.No transseptal puncture was performed and there was no evidence of a steam pop.It is unknown if extended hospitalization was required.The pigtail catheter was still in the patient for drainage.The patient was reported to be in stable condition and fully recovered.The physician¿s opinion regarding the cause of the adverse event is that it was caused by a right ventricle (rv) webster 6 pole catheter.No bwi product malfunctions were reported.Transseptal puncture was not performed.No ablation was done prior to the adverse event.The flow setting was at low flow of 2ml.No error messages were observed on any bwi equipment.The force visualization features used included dashboard, vector and visitag.The parameters for stability used were impedance drop for color, 2mm for 4 sec.No additional filter was used.The color option used prospectively was impedance drop.
Additional Manufacturer Narrative
Additional information was received on 1/20/2020 indicating both catheters (thermocool® smart touch® sf bi-directional navigation catheter & webster¿ electrophysiology catheter) were used.The female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with both thermocool® smart touch® sf bi-directional navigation catheter & webster¿ electrophysiology catheters and suffered cardiac tamponade requiring pericardiocentesis.The thermocool® smart touch® sf bi-directional navigation catheter was reported in the initial report.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: WEBSTER ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9603669
• Report Number: 2029046-2020-00106
• Device Sequence Number: 10899549
• Product Code: LDF
• UDI-Device Identifier: 10846835001181
• UDI-Public: 10846835001181
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: 1086259RT
• Device Catalogue Number: 1086259RT
• Device Lot Number: 30315387M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/15/2020
• 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: CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention