MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) PERMANENT SLED; ILAB ULTRASOUND IMAGING SYSTEM

Model Number H749393160100

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2018-02040 and 2134265-2018-02376.It was reported that automatic pullback failure occurred.A 100v ilab ultrasound imaging system was used in conjunction with an imaging catheter and pullback sled to view the target lesion.During procedure, it was noted that automatic pullback was unable to performed.However, manual pullback was able to be performed.No patient complications were reported.

• Brand Name: PERMANENT SLED
• Type of Device: ILAB ULTRASOUND IMAGING SYSTEM
• 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: 7339244
• MDR Text Key: 102467865
• Report Number: 2134265-2018-02374
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K152316
• 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: 02/27/2018

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: H749393160100
• Device Catalogue Number: 39316-010
• Device Lot Number: 0019225499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1