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

Model Number 8864

Device Problem Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2018

Event Type  malfunction  

Event Description

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.During the procedure, auto pullback was unable to be performed and automatic pullback failed.However, the technician reported that after sled reseating the issue was solved.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: 7842879
• MDR Text Key: 119156131
• Report Number: 2134265-2018-60523
• 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,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• 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: 0000007069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1