MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYSTEM ACCESSORY; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 8815

Device Problem Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

Device not returning.

Event Description

It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a sled to perform automatic pullback.However, it was unable to perform pullback.Thus, automatic pullback failed.Furthermore, no problem was encountered during testing now.Recently, pullback often stops.No patient complications were reported.

• Brand Name: SYSTEM ACCESSORY
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• 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: 7772647
• MDR Text Key: 116873147
• Report Number: 2134265-2018-60017
• Device Sequence Number: 1
• Product Code: DQK
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8815
• Device Catalogue Number: 8815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1