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

Model Number D134804

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

Patient Problems Pleural Effusion (2010); Cardiac Tamponade (2226)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded; therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.Concomitant products: visitag surpoint epu (model# d160801, serial# (b)(4)).Manufacture ref no: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a cardiac ablation procedure with a thermocool smart touch sf bidirectional catheter and suffered cardiac tamponade requiring pericardiocentesis.At an unspecified point, cardiac tamponade was confirmed.An unspecified medication was administered.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.Issue is recovering.Extended hospitalization was required as a result of the adverse event.The principal investigator assessed the event as mild in severity, serious, not related to the study device (visitag surpoiny epu), causal related to the study catheters, not related to the biosense webster inc.(bwi) non-investigational device and causal index procedure related.

Manufacturer Narrative

It was reported that a 77-year-old female patient underwent a cardiac ablation procedure with a thermocool smart touch sf bidirectional catheter and suffered cardiac tamponade requiring pericardiocentesis.In the initial report, the manufacture address was erroneously reported as 31 technology dr.Irvine, ca 92618.The correct address is 33 technology dr.Irvine, ca 92618.Section d3 of this report has been updated.On 4/8/2019, a manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.Manufacturer ref no:(b)(4).

Manufacturer Narrative

It was reported that a 77-year-old female patient underwent a cardiac ablation procedure with a thermocool smart touch sf bidirectional catheter and suffered cardiac tamponade requiring pericardiocentesis.Additional information was received 7/3/2019, indicating 76 applications of radio frequency was delivered from the thermocool smart touch sf bidirectional catheter.On post-procedure day 11 ((b)(6) 2019) the patient developed bilateral pleural effusion.No device deficiency was reported.An unspecified medication was administered.Extended hospitalization was required as a result of the adverse event.Issue was resolved.The principal investigator assessed the event as moderate in severity, serious, not related to the study device (visitag surpoint external processing unit), not related to the study catheter, not related to the biosense webster inc.Non-investigational device and causal index procedure related.Manufacture ref no: (b)(4).

Manufacturer Narrative

On(b)(6)2020 , biosense webster inc.Received additional information indicating the patient had ¿recovered¿ from the adverse event of cardiac tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Correction: it was noticed that the concomitant products were inadvertently omitted from previously reported medwatch reports.The following items have now been added to section d11.Concomitant med.Products: visitag surpoint external processing unit (epu), smartablate generator kit-ww, thermocool smarttouchsf/st interface cable, carto 3 v6.0 system, carto external reference patches, smartablate irrigation pump.Correction: it was noticed the h6.Patient code of 2010 ¿pleural effusion¿ was inadvertently omitted from the supplemental mdr # 2.It has now been added.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology dr.; irvine CA 92618
• MDR Report Key: 8491632
• MDR Text Key: 141203489
• Report Number: 2029046-2019-02957
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2020
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30159960L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 04/08/2019; 07/03/2019; 05/11/2020
• Supplement Dates FDA Received: 05/01/2019; 07/25/2019; 06/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; CBL, 34 HYP/34 LEMO, 10'; SEE H10 SECTION; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; VISITAG SURPOINT EPU
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 89