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 Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the sled was not returned for evaluation; therefore, the functional check and initial condition analysis could not be performed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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: 2134265-2018-05394 and 2134265-2018-05876.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.During percutaneous coronary intervention, the device was unable to pullback automatically.The procedure was completed with another of the same device.No patient complications were reported and patient was stable.

• 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: 7609761
• MDR Text Key: 111345098
• Report Number: 2134265-2018-05393
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 05/28/2018

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: 01/28/2019
• Device Model Number: H749A70200
• Device Catalogue Number: A7020
• Device Lot Number: S1005039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• 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