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

Model Number D138502

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

Patient Problem Cardiac Tamponade (2226)

Event Date 02/11/2021

Event Type  Death  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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) underwent premature ventricular contraction ablation (pvc) with a carto vizigo" 8.5f bi-directional guiding sheath - medium and suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and death.After transseptal puncture the mitral valve (not the tricuspid valve) was passed to proceed with mapping and ablation using the smarttouch sf catheter.During the mapping, the specialist noticed a pericardial effusion in the intracardiac echo (ice) image.The physician stated the perforation could be at the moment of the transseptal puncture.An epicardial puncture was performed to drain the blood.Then it was determined necessary to open the chest to close the perforation, finding a perforation from the inferior vena cava to the right atrium.The physician also stated the 8mm perforation in the vena cava to the right atrium could be done in the surgery done to repair the perforation not in the ablation procedure.The patient passed away during the second procedure.Since the event is life-threatening and required intervention 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 3/10/2021, bwi received additional event information which indicates the following: the physician¿s opinion on the cause of this adverse event: procedure.When the pericardial effusion was discovered on the intracardiac echo image the physician proceeded with the an epicardial puncture to drain the blood.Then, after approximately 1 hour it was necessary to perform a 2nd surgery with open chest close the perforation on the heart.The patient died.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 - MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11431388
• MDR Text Key: 238304204
• Report Number: 2029046-2021-00266
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTTOUCH SF CATHETER.; UNK_TRANSEPTAL NEEDLE.; SMARTTOUCH SF CATHETER; UNK_TRANSEPTAL NEEDLE
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 47