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 Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

A manufacturing record evaluation was performed for the finished device 30324020l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).(b)(4).

Event Description

It was reported that a (b)(6)-year-old female patient underwent a pulmonary vein isolation (pvi) ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Following sheath removal at the end of the procedure, the patient¿s blood pressure dropped.Cardiac echocardiography was performed, and cardiac tamponade was confirmed.Pericardiocentesis was performed to remove approximately 500 ml of blood from the pericardial space, and the blood pressure recovered.Following a period of observation, a further amount of blood was aspirated.With continued blood loss, the patient was taken to cardiothoracic theatre.Thoracotomy was performed, and a small perforation to the left atrial appendage (laa) was identified and repaired.Extended hospitalization was required as a result of the adverse event.Patient¿s condition improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.Transseptal puncture was performed during the case.There was no evidence of steam pop during the ablation.The catheter irrigation was set within normal parameters for stsf catheter per the instructions for use.The force visualization features used included graph, dashboard, vector and visitag.No biosense webster product malfunctions nor error messages were reported.

Manufacturer Narrative

On(b)(6)2020 , the bwi product analysis lab received the device for evaluation.On(b)(6)2020 , the product investigation was completed.It was reported that a 73-year-old female patient underwent a pulmonary vein isolation (pvi) ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Following sheath removal at the end of the procedure, the patient¿s blood pressure dropped.Cardiac echocardiography was performed, and cardiac tamponade was confirmed.Pericardiocentesis was performed to remove approximately 500 ml of blood from the pericardial space, and the blood pressure recovered.Following a period of observation, a further amount of blood was aspirated.With continued blood loss, the patient was taken to cardiothoracic theatre.Thoracotomy was performed, and a small perforation to the left atrial appendage (laa) was identified and repaired.Extended hospitalization was required as a result of the adverse event.Patient¿s condition improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.Device evaluation details: 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 related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000724417.

• 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: 10333862
• MDR Text Key: 201878939
• Report Number: 2029046-2020-00955
• 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
• Report Date: 07/02/2020

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: 12/04/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30324020L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, D, 2-6-2; UNKNOWN TRANSSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR