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

Catalog Number UNK_CARTO VIZIGO SHEATH

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

Patient Problem Cardiac Tamponade (2226)

Event Date 03/31/2021

Event Type  Death  

Manufacturer Narrative

Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Note: the provided lot number was not recognized as a valid lot number in our system, as such, the manufactured date and the expiration dates could not be obtained.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(4) female patient with history of complications with groin access/compact syndrome during previous ablation procedure that resulted in multiple surgeries underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath and suffered cardiac tamponade (requiring pericardiocentesis) and death.During the procedure, the physician inserted a cs catheter and a carto vizigo¿ 8.5f bi-directional guiding sheath in preparation for a transseptal puncture.The physician stated that puncture was difficult due to the patient having strange anatomy.Once he was over to the left atrium (la), he was manipulating a wire in the chamber under fluoroscopic guidance.He then realized the patient's blood pressure was dropping.An echocardiogram was performed, and a pericardial effusion was noted.Pericardiocentesis was done to drain the blood from the pericardium.Reminder of the procedure was aborted.Cardiac tamponade was resolved in the ep lab and the patient was stable when they left the ep lab.No bwi ablation catheter was used.No ablation was ever done.While the patient was in the lab, blood gas levels (mainly co2) were not maintained at an appropriate level.This combined with hypotension directed the patient to the icu.The doctor stated that the patient was very sick and not able to withstand these two things combined together.It was something that happened too fast for the patient's body to handle and recover from.Physician¿s opinion regarding the cause of the event it was related to the patient¿s condition and anatomy.

Manufacturer Narrative

On 28-jun-2021, biosense webster inc.Received additional information indicating the physician stated they had no complaint against the carto vizigo¿ 8.5f bi-directional guiding sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref#: (b)(4) correction: it was noticed that field g1.Manufacturer site city, was misspelled in the 3500a initial medwatch report as ¿irivine¿ and has now been corrected to ¿irvine¿.

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11724249
• MDR Text Key: 247262184
• Report Number: 2029046-2021-00660
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_CARTO VIZIGO SHEATH
• Device Lot Number: (01)1084683516277
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; CARTO 3 SYSTEM
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 32 YR