MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number	BD710DF282CT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30290839m, and no internal actions related to the reported complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2020-00130 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter); (2) mfr # 2029046-2020-00131 for product code bd710df282ct (webster ® cs catheter with ez steer® technology and auto id).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient underwent an atrioventricular reentrant tachycardia (avrt)/ wolff-parkinson-white syndrome (wpw) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a webster ® cs catheter with ez steer® technology and auto id and the patient suffered cardiac tamponade requiring pericardiocentesis.Towards the end of the case (post-ablation phase), the patient¿s blood pressure declined while pacing.The blood pressure raised back up to an acceptable level and the procedure continued.Post-testing with re-insertion of intracardiac echocardiography (ice), pericardial effusion was discovered by ultrasound ice.Cardiac tamponade was confirmed by ice and transthoracic echo (tte).Pericardiocentesis was performed and 320ml of fluid was removed from the pericardial space.The patient stayed overnight for monitoring.Patient condition improved, the physician said the patient remained stable.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, he believed the event occurred during the manipulation of right ventricle (rv) or the coronary sinus (cs) catheters post-ablation.The rv catheter used was a st jude josephson quad (non-bwi product) transseptal puncture was performed with a st.Jude medical brk 98cm transseptal needle.There was no evidence of steam pop during the ablation.The catheter irrigation was set at 2ml, 8ml and 15ml.No error messages were observed on any bwi equipment.The force visualization features used included graph, dashboard, vector and visitag.The parameters for stability used with the visitag module were 2mm for 7 seconds, 25% at 2gms.No additional filter was used.The color option used prospectively was time (custom 10-30 seconds).It is the physician¿s opinion that the adverse event occurred during the manipulation of rv (non-bwi product) or cs catheter; however, since the cardiac tamponade was noticed after the ablation already had been performed with the thermocool® smart touch® sf bi-directional navigation catheter, the event will be conservatively coded and reported under both products (thermocool® smart touch® sf bi-directional navigation catheter and webster ® cs catheter with ez steer® technology and auto id).

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9618333
• Report Number: 2029046-2020-00131
• Device Sequence Number: 11432153
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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: 09/11/2022
• Device Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 30290839M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/22/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 70 YR