MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_PENTARAY

Catalog Number UNK_PENTARAY

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Nerve Damage (1979); Transient Ischemic Attack (2109); Urinary Tract Infection (2120); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the 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.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: wang a, truong t, black-maier e, green c, campbell kb, barnett as, febre j, loring z, al-khatib sm, atwater bd, daubert jp, frazier-mills c, hegland dd, jackson kp, jackson lr, koontz ji, lewis rk, pokorney sd, sun ay, thomas kl, bahnson td, piccini jp.Catheter ablation of atrial fibrillation in patients with diabetes mellitus.Heart rhythm o2.2020 may 12;1(3):180-188.Doi: 10.1016/j.Hroo.2020.04.006.Pmid: 34113872; pmcid: pmc8183889.Objective: diabetes mellitus (dm) is an independent risk factor for atrial fibrillation (af).Few studies have compared clinical outcomes after catheter ablation between patients with and those without dm.The purpose of this study was to compare af ablation outcomes in patients with and those without dm.Methods/study data: this was an observational, retrospective cohort study performed within the duke center for atrial fibrillation.A total of 351 patients receiving first time ablation between december 5, 2014, to january 28, 2016 were included.All patients had routine clinic follow-up visits and 12-lead ecgs scheduled at 3-, 6-, 9-, and 12-months post procedure and on a yearly basis thereafter, with more frequent follow-up in the presence of recurrent arrhythmia or symptoms.In addition, symptom burden and adverse events were determined by phone calls at 1 week, and 3, 6, and 12 months after the procedure.Transseptal puncture was performed under direct visualization by intra- cardiac echocardiography.Pulmonary vein isolation was per- formed using continuous or point-to-point circumferential ablation with contact force-sensing open-tipped irrigated catheters.Electroanatomic mapping systems (carto, bwi or navx, abbott) were used in all cases.Entrance and exit block were confirmed with a circular catheter or a high- resolution mapping catheter (pentaray, bwi), and adenosine, isoproterenol, or burst pacing was administered at the operator¿s discretion.The manufacturer of the ablation catheters utilized in this study are not specified within the text of this article.All-cause periprocedural adverse events were infrequent and did not differ between the 2 groups and will be detailed below.The authors concluded that although safety outcomes associated with af ablation were similar between patients with and those without dm, arrhythmia-free survival was significantly lower among patients with dm.Poor glycemic control seems to an important risk factor for af recurrence.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: pentary diagnostic catheter to confirm entrance and exit block.Other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions: please note: the authors do not specify the treatment for any of the periprocedureal complications: 5 patients with access site bleeding 4 patients with acute heart failure 5 patients with proarrhythmia - at/afl 2 patients with phrenic nerve paralysis 8 patients with urinary tract infection the following adverse events were associated with rehospitalization in the follow-up period.Treatment during the hospitalization was not specified.32 patients with arrhythmia 11 patients with heart failure 3 patients with myocardial infarction 4 patients with significant bleeding 3 patients with stroke/tia".

• Brand Name: UNK_PENTARAY
• Type of Device: UNK_PENTARAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine 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: 12389409
• MDR Text Key: 268899729
• Report Number: 2029046-2021-01440
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_PENTARAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2021
• 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
• Patient Outcome(s): Other