MAUDE Adverse Event Report: ARDEN HILLS, MN INTELLANAV¿ MIFI XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number UNK882

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

Device not returned therefore analysis of complaint device could not be performed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as: 2134265-2018-06508, 2134265-2018-06509.It was reported that patient experienced a pericardial effusion.During an atrial fibrillation ablation procedure performed on (b)(6) 2018 in which an intellanav mifi xp ablation catheter, an intellamap orion catheter and a dynamic xt catheter were used, the patient experienced a pericardial effusion.The effusion occurred after a series of 9 rf ablations (following 15 minutes of mapping with the orion catheter) in the anterior wall, close to the left atrial appendage ostium.The company representative present at the procedure did not observe any strange impedance values or value variations and the intellanav mifi xp catheter did not go out of geometry.For the first 8 rf lesions, the generator parameters were: 35w, 30 degrees c, approximately 90 ohms.The 9th lesion generator parameter was 30w, 30 degrees c, approximately 87 ohms.The average impedance drop for the 9 rf ablations was 15 to 25 ohms (largest = -26.4 ohms and the impedance drop for the 9th rf ablation was -20.0 ohms).The starting impedance value was around 105 ohms for every rf application with 115 ohms being the good tissue contact impedance reference.The effusion was noticed immediately by the physician because the patient¿s blood pressure had decreased rapidly.The physician suspected that the last rf ablation was responsible for the effusion.One liter of blood was drained from the patient¿s pericardium and he was transferred to the surgery lab.The patient stabilized after 30 minutes and remained stable after 24 hours.

• Brand Name: INTELLANAV¿ MIFI XP TEMPERATURE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7721772
• MDR Text Key: 115080362
• Report Number: 2134265-2018-06507
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2018

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: UNK882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/26/2018
• 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
• Treatment: DYNAMIC XT: BOSTON SCIENTIFIC; INTELLAMAP ORION: BOSTON SCIENTIFIC; ZURPAZ SHEATH: CREGANNIA MEDICAL
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR