MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_PENTARAY; UNKNOWN

Catalog Number UNK_PENTARAY

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

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).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 the lot number was provided by the customer.(b)(4).The following manufacturer report numbers: 2029046-2020-01607.2029046-2020-01608.2029046-2020-01609.2029046-2020-01610.2029046-2020-01611.2029046-2020-01612.2029046-2020-01613.2029046-2020-01614.2029046-2020-01615.2029046-2020-01616.2029046-2020-01617.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: major immediate less than or equal to 4 hours post operation: it was reported that 1 patient underwent ablation aided by 3d mapping and point by point ablation with the pentaray and suffered a vascular bleed.Surgical intervention was required.Other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: velocity/precision with optima, hd-grid mapping catheter.Publication details.Title: safety and cost-effectiveness of same-day complex left atrial ablation.Objective: catheter ablation for complex left-atrial arrhythmia is increasing worldwide with many centres admitting patients overnight.Same-day procedures using conscious sedation carry significant benefits to patients/healthcare providers but data are limited.We evaluated the safety and cost-effectiveness of same-day complex left-atrial arrhythmia ablation.Methods: multi-centre retrospective cohort study of all consecutive complex elective left-atrial ablation procedures performed between january 2011 and december 2019.Data were collected on planned same-day discharge versus overnight stay, baseline parameters, procedure details/success, ablation technology, post-operative complications, unplanned overnight admissions/outcomes at 4-months and mortality up to april 2020.A cost analysis of potential savings was also performed.

• Brand Name: UNK_PENTARAY
• Type of Device: UNKNOWN
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10773345
• MDR Text Key: 214325540
• Report Number: 2029046-2020-01606
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PENTARAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR