MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 8864

Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  malfunction  

Event Description

It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an opticross imaging catheter and pullback sled to view the target lesion.During procedure, an image froze during imaging and mdu overload message was displayed.The device froze during pullback.No patient complications were reported.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7886036
• MDR Text Key: 120577079
• Report Number: 2134265-2018-61068
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729761235
• UDI-Public: 08714729761235
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151613
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8864
• Device Catalogue Number: 8864
• Device Lot Number: 0000007420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1