MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749ILAB120CARTR0

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Thrombosis (2100)

Event Date 03/02/2015

Event Type  Injury  

Event Description

Same case as 2134265-2015-01983.It was reported that a thrombus formation occurred.The target lesion was located at the left anterior descending coronary artery.During percutaneous coronary intervention (pci,) an icross¿ coronary imaging catheter was used to conduct an intravascular ultrasound (ivus) at the target lesion.Upon ivus, the ilab ultrasound imaging system displayed a reboot message.The ilab system was rebooted then went ahead with the second ivus.During the second ivus, the physician noticed some clot at the target lesion and stented the clot with an unspecified bsc stent.The procedure was completed with the same device.No patient complications were reported.

Manufacturer Narrative

The complaint device was returned for evaluation.Evaluation of the returned device revealed that a hard drive error was displayed on the system screen, the acq failed functions check test.The gold system booted up with no failures observed and the image pc passed functions check test.No other issues were noted.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4642004
• MDR Text Key: 16186194
• Report Number: 2134265-2015-02038
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749ILAB120CARTR0
• Device Lot Number: 0000007027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention