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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR

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BOSTON SCIENTIFIC CORPORATION OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 44021
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/27/2020
Event Type  malfunction  
Event Description
It was reported that tip detachment/separation occurred. The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac. An opticross 18 jp imaging catheter was advanced for use. Treatment for the stenosis for the lesion was performed in both sides of the iliac with a brachial artery approach. After placing one epic device in the right external iliac artery, two more epic devices were placed from the left common iliac artery to the external iliac artery. When trying to confirm the placement site of the stent in the left via ivus, it was felt that the ivus catheter was caught at the joint part of the two stents. When the catheter was pulled and removed from the sheath, about 6mm of the tip of this device got separated/detached. It was confirmed under fluoroscopy that the tip remained inside the patients body. For that reason, the procedure was completed by placing one more epic device from the inside of one stent, and in the form of pressing it down to the outside. The patient is safe, but the existing lameness symptoms have improved.
 
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Brand NameOPTICROSS 18
Type of DeviceCATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10197019
MDR Text Key196489258
Report Number2134265-2020-07938
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/16/2022
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0025220934
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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