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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.
 
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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 johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11741160
MDR Text Key247931830
Report Number2134265-2021-05427
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 06/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0026606715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2021
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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