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

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

The patient code "no code available" is being used to represent the surgical intervention and prolonged hospitalization.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an (b)(6) female patient with history of premature ventricular contractions (pvcs) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.At the beginning of the procedure, the decanav catheter could not be selected for mapping.The case on the workstation was abandoned and a new case was created, and the procedure continued.Transseptal puncture was then done with a baylis rf transseptal needle, and a small pericardial effusion was discovered before any ablation had been done.The physician then decided to map and ablate with the stsf, but didn¿t want to proceed after they discovered by intracardiac echocardiography (ice) that the effusion was getting bigger during the ablation.They confirmed by transthoracic echocardiography (tte) that the effusion was bigger.The patient was sent to recovery, and while in recovery had a drop in blood pressure.Patient was brought back to the lab.It was confirmed by tte that the effusion once again increased in size.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.The patient was moved to the operating room and required open heart surgery.The physician stated the surgeon found oozing from an area near the ablation site.The patient was moved to the intensive care unit (icu) after surgery for recovery and required extended hospitalization.Patient¿s condition improved.There was no evidence of steam pop during the ablation.The catheter irrigation was set at 8ml/min.The force visualization features used were graph, dashboard, vector, and visitag.The parameters for stability used with the visitag module were 2mm x 5 seconds, 5gm 25% fot.Tag size 3mm.Impedance drop was used as color option.Since this event is life threatening and required medical intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 10/12/2020, the product investigation was completed as the complaint device has not been returned.It was reported that an 87-year-old female patient with history of premature ventricular contractions (pvcs) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.At the beginning of the procedure, the decanav catheter could not be selected for mapping.The case on the workstation was abandoned and a new case was created, and the procedure continued.Transseptal puncture was then done with a baylis rf transseptal needle, and a small pericardial effusion was discovered before any ablation had been done.The physician then decided to map and ablate with the stsf, but didn¿t want to proceed after they discovered by intracardiac echocardiography (ice) that the effusion was getting bigger during the ablation.They confirmed by transthoracic echocardiography (tte) that the effusion was bigger.The patient was sent to recovery, and while in recovery had a drop in blood pressure.Patient was brought back to the lab.It was confirmed by tte that the effusion once again increased in size.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.The patient was moved to the operating room and required open heart surgery.The physician stated the surgeon found oozing from an area near the ablation site.The patient was moved to the intensive care unit (icu) after surgery for recovery and required extended hospitalization.Patient¿s condition improved.Device investigation details: since this event is life threatening and required medical intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.As a result, the mre review cannot be conducted.Should the correct lot number be made available at a later date, the complaint file will be reopened and an mre review will be performed and documented.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10570934
• MDR Text Key: 208783181
• Report Number: 2029046-2020-01258
• 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
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAYLIS TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; DECANAV CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR