MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number H749ILAB100C270

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 2134265-2017-13358 and 2134265-2017-13357.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.It froze last weekend, thus automatic pullback failure occurred.However, today error 119 was displayed for several times.No patient complications were reported.

Event Description

Same case as 2134265-2017-13358 and 2134265-2017-13357.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.It froze last weekend, thus automatic pullback failure occurred.However, today error 119 was displayed for several times.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed the product was received in good condition with no visible damage observed.Acqpc and imgpc were installed into a gold standard system and tested for functionality.The acq pc was unable to meet specification due to a defective cooling cpu fan on the acq pc mother pca board causing overheating and a 119 acq pc connection issue.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion isolated the failure to a specific component within a bsc system or assembly which contributed to the event; however the cause for the component failure is unknown.(b)(4).

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• 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: 7179870
• MDR Text Key: 96970118
• Report Number: 2134265-2017-13264
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 12/25/2017

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: H749ILAB100C270
• Device Catalogue Number: ILAB100C27
• Device Lot Number: 0000010344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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