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

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.

• Brand Name: OPTICROSS 18
• Type of Device: CATHETER, 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 Key: 10197019
• MDR Text Key: 196489258
• Report Number: 2134265-2020-07938
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• 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 Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/16/2022
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0025220934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial