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 Consequences Or Impact To Patient (2199)

Event Date 09/02/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that automatic pullback failure occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.An ilab ultrasound imaging system was used in conjunction with an opticross imaging catheter and a pullback sled to perform automatic pullback.However, it became unable to perform pullback on the mid-way.The procedure was performed again and completed after the catheter was replaced and the main equipment was restarted.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: 7893698
• MDR Text Key: 120973547
• Report Number: 2134265-2018-61163
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• 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: 09/03/2018
• 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