MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

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

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Fever (1858); Hematoma (1884); Hemorrhage/Bleeding (1888); Pneumonia (2011); Tachycardia (2095); Urinary Retention (2119); Hematuria (2558); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the event date is unknown, article published 2021-1.The device is not expected to be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

Latcu dg, enache b, hasni k, wedn am, zarqane n, pathak a, saoudi n, sequential ultrahigh-density contact mapping of persistent atrial fibrillation: an efficient technique for driver identification.J cardiovasc electrophysiol.2020.Between march 2015 and august 2019, 90 patients (74% men, 66 +/- 9 years) had a persistent af ablation procedure (using the rhythmia system) in our center.Detailed patient characteristics are given in table s1.Twenty patients had a previous af ablation (19 catheter ablation and one surgical maze) and 21 arrived in the operating room in sr or at.For the remaining 51 patients without previous af ablation the procedure was performed in spontaneous (not induced) af.They were labeled "de novo af" group and included for further analysis and report of acute and long-term results.In 72.5% of de novo af cases, a non-boston scientific catheter was used, in 25.5%, the intellanav mifi oi and in the remaining patient another non-boston scientific catheter.The ablation catheter was inserted via the zurpaz deflectable sheath in 98% (in the magnetic navigation case the v-cas deflect sheath was used).Details about the outcome during and immediately after the procedure are presented in figure 6.All patients had cpvi with confirmation of entry block for those with procedural af termination.The mean rf delivery time for cpvi was 40.5 +/- 13.1 min.This step led to af termination in nine patients (17.6%).Extra-pv potential driver ablation was then performed in the remaining (n = 42), with a mean rf delivery time of 12.2 +/- 7.9 min.At this stage af terminated in 13 (25.4%) additional patients (3 in sr and 10 in at).Only two patients (3.9%) had potential driver ablation in the ra (ablation times 149 and 297 s, respectively) without af termination.For patients with per procedural at additional mapping and ablation (rf: 13 +/- 12 min) was performed, up to sr resumption.During the first 48 h after the procedure there were an additional 12 af "spontaneous" terminations (23.5%; 4 to sr and 8 to at), bringing the overall af termination rate to 66.6%.Before discharge 17 patients had an electrical cardioversion for continuing af and eight for ongoing at.The total procedure time was 303 +/- 55 min with a fluoroscopy time of 16.2 +/- 7.4 min.There were no major complications in this patient series.Cardiac complications recorded in the entire study population (n = 90) were represented by four patients with pericardial pain (none with effusion) and one patient with postoperative acute heart failure, regressive with medical treatment.Extracardiac complications were transient fever in 12 patients, attributed to suspected infectious pneumonia in nine, all treated successfully with probabilistic antibiotics.There was one minor spontaneously curable groin hematoma, one hemorrhagic complication (epistaxis) requiring transfusion, one minor hematuria and one urinary retention.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora, heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11381748
• MDR Text Key: 233744325
• Report Number: 2134265-2021-02421
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: MN
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; ZURPAZ SHEATH
• Patient Outcome(s): Other; Required Intervention