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

Model Number H749393160100

Device Problem Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as: 2134265-2018-03399 and 2134265-2018-03701.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and pullback sled to view the target lesion.During the procedure, it was noted that the motor drive unit 5 plus (mdu5+) became unable to perform automatic pullback.However, after replacing with disposable sled, it was able to perform auto-pullback, but the issue continuously occurred.No patient complications were reported.

• Brand Name: PERMANENT SLED
• Type of Device: ILAB ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7447028
• MDR Text Key: 106053431
• Report Number: 2134265-2018-03702
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1