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 Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Hematoma (1884); Pseudoaneurysm (2605)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: rajendra a, hunter td, morales gx, zei p, boo lm, varley a, osorio j.Steerable sheath visualizable under 3d electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy.J interv card electrophysiol.2022 aug 10.Doi: 10.1007/s10840-022-01332-8.Epub ahead of print.Erratum in: j interv card electrophysiol.2022 sep 6;: pmid: 35947317.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same article.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: rajendra a, hunter td, morales gx, zei p, boo lm, varley a, osorio j.Steerable sheath visualizable under 3d electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy.J interv card electrophysiol.2022 aug 10.Doi: 10.1007/s10840-022-01332-8.Epub ahead of print.Erratum in: j interv card electrophysiol.2022 sep 6;: pmid: 35947317.Objective/methods/study data: the objective of this study was to demonstrate feasibility, safety, procedural efficiency, and clinical effectiveness of incorporating the new visualizable sheath into a low-fluoroscopy workflow.The study population included patients having de novo paf ablation performed by one of three operators at a single high volume site between january 2018 and may 2019.Cohorts of interest were defined by procedures that utilized a vizigo sheath vizigo cohort) versus those that did not (non-vizigo cohort).All patients underwent their first left atrial ablation with the thermocool smarttouch® sf catheter (stsf; biosense webster, inc., irvine, ca) and were evaluated according to standard clinical practices at the study site.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch® sf catheter.Other biosense webster devices that were also used in this study: carto visitag¿ sheath.Non-biosense webster devices that were also used in this study: fast-cath sl2 preformed sheath (sl2; st.Jude medical, inc., (b)(4), pinnacle introducer sheath (terumo medical corporation, (b)(4), multipolar pentaray catheter (biosense webster, inc.,(b)(4).Adverse event(s) and provided interventions: qty 1- arteriovenous fistula (vizigo cohort).Qty 2- cardiac tamponade ( 1 in vizigo cohort and 1 in non-vizigo cohort requiring pericardiocentesis).Qty 2 - hematoma (vizigo cohort).Qty 2 - pseudoaneurysm (1 in vizigo cohort and 1 in non-vizigo cohort requiring femoral artery repair.).Qty 1- pericarditis (vizigo cohort).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15682560
• MDR Text Key: 302568400
• Report Number: 2029046-2022-02662
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FAST-CATH SL2 PREFORMED SHEATH.; MULTIPOLAR PENTARAY CATHETER.; PINNACLE INTRODUCER SHEATH.
• Patient Outcome(s): Other