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

Model Number D138501

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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) year-old female patient ((b)(6) kg) underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, a single difficult transseptal approach was done with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and sl0 transseptal needle from st.Jude medical.Stsf was then used for fast anatomical mapping (fam).Fam merged to ct.The stsf catheter was zeroed before taking drop off points.The stsf was then advanced into the right inferior pulmonary vein (ripv).Ablation of the left superior pulmonary vein (lspv) anterior ridge.On the 4th radiofrequency lesion, an audible pop was heard by the operator.1.5 minute later, the patient¿s blood pressure dropped to 60/40.The physician called for a pericardiocentesis drain kit and a consultant to assist.All catheters were withdrawn.Overall took 10-15mins to gain access to pericardium.Once access was obtained, pericardiocentesis was done and ~1l was removed from pericardial space.Patient¿s blood pressure returned to normal following after drainage.Surgeons on standby wait time of 30 minutes.Surgeon decided to place a surgical drain for overnight surveillance.Patient required prolonged hospitalization in the intensive care unit to ensure patient does not relapse.Patient¿s condition had improved.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.No bwi product malfunctions were reported.The catheter irrigation was set at 15ml/hour.The pump was switching from low to high flow during the ablation.The correct catheter settings were selected on the generator.No error messages were reported.Graph, dashboard, vector and visitag were used as visualization features.The parameters for stability used were 3mm range, 3second time, fot = 30% at 3g, tag size 2mm.Ablation index, anterior preset: low 400, anterior 500 were used as coloring option.Since the event is life-threatening and required intervention to prevent permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6)2021, the product investigation was completed.It was reported that a 70-year-old female patient (50 kg) underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, a single difficult transseptal approach was done with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and sl0 transseptal needle from st.Jude medical.Stsf was then used for fast anatomical mapping (fam).Fam merged to ct.The stsf catheter was zeroed before taking drop off points.The stsf was then advanced into the right inferior pulmonary vein (ripv).Ablation of the left superior pulmonary vein (lspv) anterior ridge.On the 4th radiofrequency lesion, an audible pop was heard by the operator.1.5 minute later, the patient¿s blood pressure dropped to 60/40.The physician called for a pericardiocentesis drain kit and a consultant to assist.All catheters were withdrawn.Overall took 10-15mins to gain access to pericardium.Once access was obtained, pericardiocentesis was done and ~1l was removed from pericardial space.Patient¿s blood pressure returned to normal following after drainage.Surgeons on standby wait time of 30 minutes.Surgeon decided to place a surgical drain for overnight surveillance.Patient required prolonged hospitalization in the intensive care unit to ensure patient does not relapse.Patient¿s condition had improved.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a evaluation of all features of the catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo per the event, several tests were performed.The carto 3 and electrical features were tested and no issues were observed.In addition, the device was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.The device history record (dhr) for the lot number 00001505 has been received and no internal action related to the complaint was found during the review.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine 92618
• MDR Report Key: 11916657
• MDR Text Key: 254037400
• Report Number: 2029046-2021-00856
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK¿ TRANSSEPTAL NEEDLES (SMJ; CARTO 3 SYSTEM; LASSO NAV; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50