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 Hematoma (1884); Hemorrhage/Bleeding (1888); Nerve Damage (1979); Obstruction/Occlusion (2422); Pericardial Effusion (3271); Ischemia Stroke (4418)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: the event date is unknown.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

Aziz z, shatz d, raiman m, upadhyay ga, beaser ad, besser sa, shatz na, fu z, jiang r, nishimura t, liao h, nayak hm, tung r.Targeted ablation of ventricular tachycardia guided by wavefront discontinuities during sinus rhythm: a new functional substrate mapping strategy.Circulation.2019; 140 (17): 1383-1397.Patients with scar-related ventricular tachycardia (vt) were prospectively enrolled in the university of chicago vt ablation registry between 2016 and 2018.Isochronal late activation maps annotated to the latest local electrogram deflection were created with high-density multielectrode mapping catheters.Targeted ablation of deceleration zone (dz) (>3 isochrones within 1cm radius) was performed, prioritizing later activated regions with maximal isochronal crowding.When possible, activation mapping of vt was performed, and successful ablation sites were compared with dz locations for mechanistic correlation.Patients were prospectively followed for vt recurrence and mortality.Procedural complications were observed in 8% (n=10) of patients in the overall cohort with 1.7% (n=2) cases resulting in procedure-related mortality.One patient, with a large chronic anterior infarction with apical aneurysm and ef of 10%, underwent ablation with hemodynamic support (intra-aortic balloon pump and impella) because of vt storm in the setting of ongoing cardiogenic shock.He suffered a large femoral hematoma from venous bleeding on the first operative day in the intensive care unit requiring 4 units packed red blood cell transfusion and albumin.Systemic anticoagulation was withheld, and the patient suffered multiple embolic strokes and care was withdrawn subsequently.The other patient died from a ruptured infected pseudoaneurysm, after systemic heparinization from a chronic indwelling arterial site for balloon pump placed previously at another hospital.Three patients had complications directly related to epicardial access.An inadvertent puncture of the superior epigastric artery manifested after sheath removal and was managed with extension of subxiphoid incision site with uncomplicated stitch repair.An anterior interventricular venous bleed likely from sheath manipulation required emergent sternotomy.Both patients are alive without recurrent vt at follow-up.One patient had 2l of epicardial bleeding after rv puncture and another had rv outflow tract perforation during endocardial mapping; both were managed conservatively with a pericardial drain.A delayed pericardial effusion occurred in another case from an obstructed drain that was successfully treated with pericardiocentesis the morning after procedure.Three femoral hematomas were observed and did not require surgical intervention.Another had femoral artery occlusion after impella placement treated with emergent angioplasty and stenting with resolution.One transient phrenic nerve palsy was observed after epicardial ablation of basal lateral substrate.

• 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: 11386292
• MDR Text Key: 233809558
• Report Number: 2134265-2021-02496
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

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: 02/26/2021
• 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 OI
• Patient Outcome(s): Death; Other; Required Intervention