MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿; CATHETER, ULTRASOUND, INTRACARDIAC

Model Number M00499120

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

Patient Problem Pericardial Effusion (3271)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the complaint device was not returned for evaluation.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that patient pericardial effusion occurred.The target lesion was located in the right and left atrium.During and atrial fibrillation ablation procedure and ultra ice plus¿ was used.The physician felt the ice images had poor quality and the physician described the patient as having a thick septum and thought that might have contributed to the poor images.The patient experienced a pericardial effusion that required surgical intervention.They aborted the procedure due to this event.Patient is now stable and doing well.

• Brand Name: ULTRA ICE PLUS¿
• Type of Device: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6795253
• MDR Text Key: 82723601
• Report Number: 2134265-2017-07872
• Device Sequence Number: 1
• Product Code: DXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00499120
• Device Catalogue Number: 9912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• 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): Required Intervention