MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE; INTRODUCER, CATHETER

Catalog Number D138503

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/16/2020

Event Type  Death  

Manufacturer Narrative

Initial reporter information (as the information for two doctors were provided): dr (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 00001270 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported a male patient underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis) and death.Patient had been transferred from derby due to frequent vt therapy from an in-situ implantable cardio defibrillator (icd device as a result of possible alcohol related cardiomyopathy last week.The case was performed under x-ray guidance and local sedation.Transseptal puncture was performed with an abbott lamb90 and brk needle which was subsequently changed to carto vizigo¿ 8.5f bi-directional guiding sheath - large.The vizigo sheath was left in the left atrium (la) i a straight position, no catheter or wire were inside.The right ventricle (rv) was mapped with a pentaray and stsf catheters.Coronary sinus (cs) was mapped with a webster cs catheter and a webster quadrapolar was placed in the his.During the case, the patient went in and out of vt which required around 12 shocks, some terminated vt and some accelerated into ventricular fibrillation (vfib) which has required further shocks.Carto v7 system has been used with parallel mapping feature to map in sinus rhythm and during vt which was hemodynamically stable.Upon successful mapping, ablation was performed with the stsf in the posterior septal base of the right ventricle outflow tract (rvot) region, power titrated between 30-50w, force value was between 20-40 gr guided by impedance drop.This has terminated the vt, 600ms.After some time during mapping, another vt focal source was found and while mapping, it was noticed the left heart wall was not mobile and the patient¿s blood pressure dropped to around 80 (at the beginning of the case, it was around 140).A global effusion was observed by echography with a 2cm rupture.Pericardiocentesis was performed to drain 1.5 liters of blood from the pericardial space.After that, the patient¿s blood pressure dropped to 50 and started to have long vt sessions.Patient expired.Physician does not have a definitely cause of the death as there¿s no post-mortem report.There was no evidence of steam pop during the ablation.Standard stsf settings were used.No bwi product malfunctions nor error messages were reported.The force visualization features used included dashboard, vector and visitag.The parameters for stability used with the visitag module were 3mm, 3s, 25%, tag size 3.Impedance drop was used as coloring option.Per medical safety officer assessment, the event described is attributable to a known complication of cardiac tamponade with this procedure.The patient¿s hemodynamic status changed with the development of pericardial effusion with an already challenged cardiac function due to underlying condition and ventricular tachycardia.The stsf catheter and the vizigo sheath may have resulted in the initial harm of cardiac tamponade which ultimately led to patient death and should be reported as such.Cardiac tamponade and the patient's death constitutes an mdr-reportable event.This report is for the carto vizigo¿ 8.5f bi-directional guiding sheath - large.The thermocool® smart touch® sf bi-directional navigation catheter will be reported under manufacturer report number 2029046-2020-01907.

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irivine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA ; 9497898687
• MDR Report Key: 10984977
• MDR Text Key: 220714016
• Report Number: 2029046-2020-01906
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2021
• Device Catalogue Number: D138503
• Device Lot Number: 00001270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT AGILIS SHEATH - LARGE; ABBOTT LAMB90; BRK TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; PENTARAY NAV; WEBSTER CS; WEBSTER QUADRAPOLAR CATHETER
• Patient Outcome(s): Death