MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRASONIC IMAGING CATHETER - CORONARY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNK97

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

Patient Problems Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

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 root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was reported that a thrombus accumulation and st elevation myocardial infarction occurred.The target lesion was located in the right coronary artery (rca).Ultrasonic imaging catheter was used during a percutaneous coronary intervention (pci) procedure.After pci was completed, thrombus accumulation and slow flow at the newly implanted stent occurred.An st elevation myocardial infarction at the right coronary artery (rca) was noted.The procedure was completed with reopening the vessels with non-compliant balloons.No further patient complications were reported and the patient¿s status is stable.

• Brand Name: ULTRASONIC IMAGING CATHETER - CORONARY
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 6116800
• MDR Text Key: 60545466
• Report Number: 2134265-2016-10536
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/31/2016

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: UNK97
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/21/2016
• 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