MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) GALAXY INTRAVASCULAR ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number H749A70200

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as 2134265-2018-00749 and 2134265-2018-00750.It was reported that automatic pullback failure occurred.The target lesion was located in left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.During a percutaneous coronary intervention (pci), it was noted that the sled could not pullback.Completed with another with same pullback sled.No patient complications were reported and patients' condition is stable.

• Brand Name: GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7225262
• MDR Text Key: 98593171
• Report Number: 2134265-2018-00578
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K980851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: H749A70200
• Device Catalogue Number: A7020
• Device Lot Number: S1004893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2017
• 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