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

Model Number 8864

Device Problems No Display/Image (1183); Retraction Problem (1536); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2018

Event Type  malfunction  

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 pullback sled to perform automatic pullback.During the procedure it was noted that the image disappeared.The mdu5+ was replaced and connected.However, it could not perform pullback.Possible that sled recognition is malfunctioning.When the sled was replaced, the issue improved.No patient complications were reported.

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 pullback sled to perform automatic pullback.During the procedure it was noted that the image disappeared.The mdu5+ was replaced and connected.However, it could not perform pullback.Possible that sled recognition is malfunctioning.When the sled was replaced, the issue improved.No patient complications were reported.Device evaluated by mfr.The device was returned for analysis with corroded pins in the catheter socket hub.Device analysis revealed that the mdu-5 plus failed the basic functional test.A defective lemo cable caused the image to intermittently disappeared.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.

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 pullback sled to perform automatic pullback.During the procedure it was noted that the image disappeared.The mdu5+ was replaced and connected.However, it could not perform pullback.Possible that sled recognition is malfunctioning.When the sled was replaced, the issue improved.No patient complications were reported.The device was returned for analysis with corroded pins in the catheter socket hub.Device analysis revealed that the mdu-5 plus failed the basic functional test.A defective lemo cable caused the image to intermittently disappeared.The pullback accessory permanent sled was also returned for analysis.The sled was returned separately, at a later date, in overall good physical condition.The returned sled could properly connect to the motor drive unit 5+ (mdu5+).When the mdu5+ was turned on, the ilab system recognized the mdu5+ in place.The test catheter was properly recognized and held firmly in place.During functional testing using a test catheter, the sled could properly pull back and performed within specifications.The sled could be manually pull back with the mdu5+ in place.There was no disconnect error message and no issue was noted when going between automatic and manual pullback.The mdu5+ was picked up by the handle, no disconnect error message.The mdu5+ was shaken holding the handle, no disconnect error message.The sled lay flat on table with no movement or shaking and all 4 rubber feet were firmly screwed in place.The reported retraction problem, no display or display failure and damaged/defective complaints were confirmed.

Manufacturer Narrative

The device was returned for analysis with corroded pins in the catheter socket hub.Device analysis revealed that the mdu-5 plus failed the basic functional test.A defective lemo cable caused the image to intermittently disappeared.The pullback accessory permanent sled was also returned for analysis.The sled was returned separately, at a later date, in overall good physical condition.The returned sled could properly connect to the motor drive unit 5+ (mdu5+).When the mdu5+ was turned on, the ilab system recognized the mdu5+ in place.The test catheter was properly recognized and held firmly in place.During functional testing using a test catheter, the sled could properly pull back and performed within specifications.The sled could be manually pull back with the mdu5+ in place.There was no disconnect error message and no issue was noted when going between automatic and manual pullback.The mdu5+ was picked up by the handle, no disconnect error message.The mdu5+ was shaken holding the handle, no disconnect error message.The sled lay flat on table with no movement or shaking and all 4 rubber feet were firmly screwed in place.The reported retraction problem, no display or display failure and damaged/defective complaints were confirmed.

• Brand Name: ILAB ULTRASOUND IMAGING SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7838613
• MDR Text Key: 119031827
• Report Number: 2134265-2018-60533
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8864
• Device Catalogue Number: 8864
• Device Lot Number: 0000010397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1