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

Catalog Number UNK_C3 WEBSTER QUADRAPOLAR WIT

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

Patient Problem Cardiac Tamponade (2226)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-03350 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter), this mfr # for product code unk_c3 webster quadripolar with auto id - fixed (webster¿ electrophysiology catheter (rv quadripolar)).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) female patient ((b)(6)) underwent a left-sided pathway ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a webster¿ electrophysiology catheter (rv quadripolar) and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, cardiac tamponade was discovered and confirmed by echo.Pericardiocentesis was performed to remove 275 ml of blood from the pericardium.The patient was reported in stable condition after pericardial drainage.The patient stayed overnight for observation purposes.Patient¿s outcome is fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, and probably occurred during the placement of the rv quadripolar catheter.Transseptal puncture was performed with a brk1 transseptal needle and a sl3 transseptal sheath.There was no evidence of steam pop during the ablation.The flow was set at 8ml/min for mapping and between 8-15ml/min during ablation.No error messages were observed on any bwi equipment.The visualization features used included graph, dashboard, vector and visitag.The parameters for stability used with the visitag were 3mm stability range for 3 seconds.3g force minimum for 25% of the time.3mm size tag.The additional filter used with visitag was surpoint.The color options used prospectively were surpoint and ablation index.Per the additional information received on 6/6/2019, the physician believed the adverse event possibly occurred during rv quadripolar catheter placement; therefore, the event will be reported under a generic bwi webster quadripolar catheter since specific product information has not been provided.Additional follow up has been sent to request the product information.Should any new information be obtained it will be assessed and processed accordingly.Despite the physician believed the issue might be related to rv quadripolar catheter placement, this event will be reported under both bwi products, as both were used during the case and there¿s no evidence to conclude the issue was not related to the ablation procedure performed with the thermocool® smart touch® sf bi-directional navigation catheter.

Manufacturer Narrative

On 7/19/2019, it was identified that additional information received on 6/25/2019 indicates the webster¿ electrophysiology catheter (rv quadripolar) was discarded.This information was inadvertently omitted from supplemental mdr # 1 that was submitted to fda on 7/18/2019.A manufacture record evaluation cannot be conducted because no lot number was provided by the customer.Method codes has been changed from device not returned to device discarded.Manufacturer's ref # (b)(4).

Manufacturer Narrative

On 6/25/2019, biosense webster inc.Received additional information about the event.It was reported that the physician believed the adverse event was possibly caused by an rv quad catheter or perhaps the coronary sinus (cs) catheter; therefore, the adverse event will also be reported under a generic code for bwi cs catheter.The specific product information is not available.Despite the physician¿s belief that the issue might be related to rv quadipolar catheter placement, this event will be reported under all three bwi products, as all three were used during the case and there¿s no evidence to conclude the issue was not related to the ablation procedure performed with the thermocool® smart touch® sf bi-directional navigation catheter, rv quad catheter or the cs catheter.As such, biosense webster manufacturer's reference number (b)(4) has three reports related to the same event: mfr # 2029046-2019-03350 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).Mfr # 2029046-2019-03349 for product code unk_c3 webster quadrapolar with auto id - fixed (webster¿ electrophysiology catheter (rv quadripolar)).Mfr # 2029046-2019-03439 for product code unk_coronary sinus catheter (cs catheter).

• Brand Name: WEBSTER ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8743694
• MDR Text Key: 149555999
• Report Number: 2029046-2019-03349
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_C3 WEBSTER QUADRAPOLAR WIT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO 3 SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 60