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 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id# 2134265-2018-01710 and 2134265-2018-01711.It was reported that automatic pullback failure occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled.During a percutaneous coronary intervention (pci) procedure, the pullback sled didn¿t perform the pullback smoothly when auto pullback was on.The physician tried to initiate the automatic pullback but it failed.The procedure was completed with another of same device.No patient complications were reported and the patient was safe.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed the sled was returned on overall good physical condition.Sled was able to properly connect to the motor drive unit 5+ (mdu5+).During functional testing using a test catheter, the sled was able to properly pull back and performed within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Same case as mdr id# 2134265-2018-01710 and 2134265-2018-01711.It was reported that automatic pullback failure occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified left anterior descending (lad) artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled.During a percutaneous coronary intervention (pci) procedure, the pullback sled didn¿t perform the pullback smoothly when auto pullback was on.The physician tried to initiate the automatic pullback but it failed.The procedure was completed with another of same device.No patient complications were reported and the patient was safe.

• 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: 7296482
• MDR Text Key: 101121974
• Report Number: 2134265-2018-01495
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

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: 09/28/2018
• Device Model Number: H749A70200
• Device Catalogue Number: A7020
• Device Lot Number: S1004939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 04/02/2018
• Supplement Dates FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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