MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE 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 Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

Same case as mdr id#: 2134265-2018-06162 and 2134265-2018-06062.It was reported that automatic pullback failure occurred.A 100v ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.During the procedure, it was noted that blue background was displayed during pullback and automatic pullback failed.The issue was resolved after restarting.No patient complications were reported.

• Brand Name: GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7656229
• MDR Text Key: 113005263
• Report Number: 2134265-2018-06161
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2018

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: 06/15/2018
• Initial Date FDA Received: 07/02/2018
• 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