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

Model Number D134805

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/01/2019

Event Type  Injury  

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a female patient underwent a left sided idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter and suffered a cardiac tamponade which required pericardiocentesis.During the procedure, post use of biosense webster inc.(bwi) products, a cardiac tamponade was discovered.Extended hospitalization was required.Pericardiocentesis was performed twice.The patient¿s condition has improved.The procedure was successfully completed.Physician¿s opinion on the cause of the event is that it is procedure related.The event possibly occurred before the ablation phase.It is unclear if it happened with the stsf ablation catheter while manipulating it inside the heart or with the 4f tetrapolar woven catheter (bard) in the right ventricle.Ablation was performed prior to noticing the cardiac tamponade.There was no evidence of steam pop.Flow setting 2 ml/s during mapping phase, 8/15 ml/s during ablation use 30/35 w.Graph, dashboard, vector and visitag force visualization features were used during the procedure.Visitag parameters were range 3mm, time 3 seconds, force over time was 25% 3 g, color option ablation index.There were no error messages observed on biosense webster equipment during the procedure.

Manufacturer Narrative

It was reported that a female patient underwent a left sided idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter and suffered a cardiac tamponade which required pericardiocentesis.The biosense webster inc.Product analysis lab received the device for evaluation.Upon initial inspection, the product revealed no physical damage.The investigational analysis completed (b)(6)2020.The device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal actions were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacture reference no: (b)(4).

Manufacturer Narrative

During an internal review on(b)(6)2020 , it was noticed that the manufacture date and expiration date were omitted in error.Section d4 expiration date has been updated with 7/9/2020 and section h4 manufacture date has been updated with 7/10/2019.Manufacture reference no: (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 drive; irvine CA 92618
• MDR Report Key: 9493227
• MDR Text Key: 188848003
• Report Number: 2029046-2019-04030
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

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: 07/09/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30248225L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/31/2020; 05/05/2020
• Supplement Dates FDA Received: 02/19/2020; 05/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BARD 4F TETRAPOLAR WOVEN CATHETER; CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, D, 4-4-4
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention