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 Patient Involvement (2645)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: 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 mdr id#: 2134265-2018-05481 and 2134265-2018-05215.It was reported that automatic pullback failure occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and pullback sled to view the target lesion.During preparation, the opticross¿ imaging catheter was checked and was able to produced and image but it was unable to performed automatic pullback.The motor drive unit 5 plus (mdu 5+) and the pullback sled were reconnected and at the same time the opticross¿ imaging catheter was also reconnected.The physician noticed lost image occurred.They reconnected it again but the opticross¿ imaging catheter unable to provide an image.The procedure was completed with another opticross¿ imaging catheter.No patient complications were reported and the patient¿s status was no injury.

• 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: 7569840
• MDR Text Key: 110113475
• Report Number: 2134265-2018-05486
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2018

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: 05/21/2018
• Initial Date FDA Received: 06/05/2018
• 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
• Treatment: GUIDE CATHETER: 6F HEARTRAIL JL3.5; GUIDEWIRE: SION; INFLATION DEVICE: ENCORE; INTRODUCER SHEATH: TERUMO 6F