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 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as 2134265-2018-02737 and 2134265-2018-02967.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system 100v was used in conjunction with an opticross imaging catheter and a pullback sled to view the target lesion.During the percutaneous coronary intervention (pci), it got freeze during pullback.However after turning the ilab main switch to off/on, error 1002 occurred and acq pc hdd access light was blinking and it did not turn on.Completed with a different device.No patient complications were reported.

• 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: 7384706
• MDR Text Key: 103950097
• Report Number: 2134265-2018-02970
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K980851
• 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: 03/15/2018

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 Model Number: H749A70200
• Device Catalogue Number: A7020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 03/30/2018
• 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: N
• Patient Sequence Number: 1