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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

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 a (b)(6) male patient (b)(6) underwent a left sided ischemic ventricular tachycardia (l-isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase with the stsf catheter, the patient¿s blood pressure dropped, and pericardial effusion was confirmed by intracardiac ultrasound.Pericardiocentesis was performed to remove 700 cc of fluid from the pericardial space.Patient was then transferred to the intensive care unit for monitoring.Pericardial drain was left in situ for one day.Prolonged hospitalization was required as a result of the adverse event.Patient had fully recovered form the event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related, the physician believes the adverse event to be caused by the manipulation of the abbot deflectable catheter being used in the right ventricle (rv) for pace.Transseptal puncture was performed with an abbott brk 1 transseptal needle.There was no evidence of steam pop during the ablation.No bwi product malfunctions nor error messages were reported.Standard flow settings for stsf were used.The force visualization features used included graph, dashboard, vector and visitag.Suropoint stability parameters were used tag index was used as coloring option.This event is being conservatively reported under the bwi ablation catheter since the issue was noticed during the ablation phase¿ therefore the radiofrequency therapy delivered from the bwi catheter cannot be excluded as a potential cause of the adverse event.Since this event is life threatening and required intervention and prolonged to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a 92-year-old male patient (90kg) underwent a left sided ischemic ventricular tachycardia (l-isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase with the stsf catheter, the patient¿s blood pressure dropped, and pericardial effusion was confirmed by intracardiac ultrasound.Pericardiocentesis was performed to remove 700 cc of fluid from the pericardial space.Patient was then transferred to the intensive care unit for monitoring.Pericardial drain was left in situ for one day.Prolonged hospitalization was required as a result of the adverse event.Patient had fully recovered form the event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related, the physician believes the adverse event to be caused by the manipulation of the abbot deflectable catheter being used in the right ventricle (rv) for pace.Transseptal puncture was performed with an abbott brk 1 transseptal needle.There was no evidence of steam pop during the ablation.No bwi product malfunctions nor error messages were reported.Standard flow settings for stsf were used.The force visualization features used included graph, dashboard, vector and visitag.Suropoint stability parameters were used tag index was used as coloring option.This event is being conservatively reported under the bwi ablation catheter since the issue was noticed during the ablation phase¿ therefore the radiofrequency therapy delivered from the bwi catheter cannot be excluded as a potential cause of the adverse event.Since this event is life threatening and required intervention and prolonged to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.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 for the finished device number, and no non-conformances related to the complaint was found during the review.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) 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: (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: 11016790
• MDR Text Key: 222698877
• Report Number: 2029046-2020-01949
• 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
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30436047M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK 1 TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 92 YR
• Patient Weight: 90