MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number H749ILAB100C270

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: device analysis revealed no visible external damage or defects observed.The unit meets specifications of mdu-5plus basic functional test.The device did not exhibit any malfunction.The returned device passed all performance criteria during analysis.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: 2134265-2018-01002 and 2134265-2018-01003.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, pullback was performed, however, it froze for 5 to 6 seconds.Reboot was performed but the issue was not resolved.No patient complications were reported.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7233885
• MDR Text Key: 98861438
• Report Number: 2134265-2018-00668
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 01/18/2018

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: H749ILAB100C270
• Device Catalogue Number: ILAB100C27
• Device Lot Number: 10036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1