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.

Event Description

It was reported that tip detachment/separated occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac with brachial artery.An opticross 18 jp imaging catheter was advanced for use.Treatment for the stenosis by the lesion was performed in both sides of iliac with brachial artery.After placing one epic device in the right external iliac artery, two epic devices were placed from left common iliac artery to external iliac artery.When trying to confirm the placement site of the stent in the left with ivus, it was felt that the ivus catheter was caught at the joint part of the two stents.When it was pulled as it was and removed from the sheath, about 6mm of the tip of this device got separated/detached, and it was confirmed under fluoroscopy that the tip remained inside the patient's 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 procedure was completed with another of the same device.The patient is safe, but the existing lameness symptoms have improved.

Manufacturer Narrative

E1: initial reporter city - (b)(6).Correction: lot number updated from 0024708180 to 0025220934.Device evaluated by mfr: the device was returned in the incorrect original box batch 24708180 and the device has the lot number 25220934 printed on it.The sheath assembly was detached near the strain relief.A section of the distal tip was missing.The sheath assembly was detached near the strain relief.A section of the distal tip was missing.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• Brand Name: OPTICROSS 18
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• 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
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1