MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_PENTARAY NAV; CARDIAC ABLATION CATHETER

Catalog Number UNK_PENTARAY NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Cardiac Tamponade (2226)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: yao y, hu f, du z, he j, shi h, zhang j, cai h, jia y, tang m, niu g, chen g, ding l, zheng l, liang e, wu l.The value of extensive catheter linear ablation on persistent atrial fibrillation (the clear-af study).Int j cardiol.2020 oct 1;316:125-129.Doi: 10.1016/j.Ijcard.2020.05.032.Epub 2020 may 24.Pmid: 32461117.Objective: the ablation therapy for persistent atrial fibrillation (peraf) is still a challenge due to the high recurrence rate.This study was aimed to investigate the value of extensive linear ablation with contact force sensing techniques for peraf.Methods/study data: two hundred and fourteen consecutive peraf or long-standing peraf patients aged 18 ~75 years were enrolled.Patients with peraf or long-standing peraf were recruited from five experienced centers.Patients were prospectively and randomly assigned to two groups according to the strategies of radiofrequency catheter ablation: group i (n=107): pvi + la roof linear ablation + laaw linear ablation with or without mitral isthmus linear ablation; group ii (n=107): pvi+la roof linear ablation with or without mitral isthmus linear ablation.Randomization will be performed with the use of an automated computer application and stratified.The primary endpoint was freedom from any documented episode of af or organized atrial tachycardia (at), which sustained more than 30 s after the performance of a single ablation procedure and outside a blanking period of 90 days.Clinical follow-up was scheduled at 1, 3, 6, 12, 18, and 24 months after the procedure.At each follow-up, resting 12-lead ecg and 24-h holter would be used to detect af recurrence or other atrial tachycardia.The authors concluded that e extensive linear ablation with contact force monitoring did not improve the long-term outcomes for peraf patients.Repeat ablation procedure showed a possible higher chance of sinus rhythm restoration during follow-up.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smart touch catheter lasso nav sas or pentaray catheters for 3d reconstruction other biosense webster devices that were also used in this study: carto 3d mapping.Non-biosense webster devices that were also used in this study: na.Adverse event(s) and provided interventions: 1 patient in group i experienced cardiac tamponade treated with pericardiocentesis.1 patient in group ii experienced a stroke 9 days post op- no treatment specified.".

• Brand Name: UNK_PENTARAY NAV
• Type of Device: CARDIAC ABLATION CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; 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: 12394706
• MDR Text Key: 269325898
• Report Number: 2029046-2021-01458
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_PENTARAY NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention