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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Event Description
It was reported that a partial detachment occurred.The 95% stenosed, 2 to 3 cm in length target lesion was located in the left superficial femoral artery with a vessel diameter of 5mm.The opticross 18 imaging catheter was introduced and during manual pullback, when the catheter was touched, a partial separation of the catheter occurred at a portion of the device that was outside the patient.The procedure was completed with another of the same device.No patient complications were reported and that patients status was stable.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed friction marks between the rotator and the retainer clip.No issues were found, the device appears to be in good conditions.No detachment was found along the catheter body.Microscopic inspection revealed the guidewire exit port was deformed but there was no detachment along the catheter body.Flushing was performed and no leak was noticed in the different joints along the catheter body, further confirming the absence of a detachment.
 
Event Description
It was reported that a partial detachment occurred.The 95% stenosed, 2 to 3 cm in length target lesion was located in the left superficial femoral artery with a vessel diameter of 5mm.The opticross 18 imaging catheter was introduced and during manual pullback, when the catheter was touched, a partial separation of the catheter occurred at a portion of the device that was outside the patient.The procedure was completed with another of the same device.No patient complications were reported and that patients status was stable.
 
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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 Key11741160
MDR Text Key247931830
Report Number2134265-2021-05427
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/30/2021
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 Expiration Date01/09/2023
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0026606715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Initial Date Manufacturer Received 04/09/2021
Initial Date FDA Received04/28/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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