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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 6 HD; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC CORPORATION OPTICROSS 6 HD; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 8669
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event approximated since unknown.
 
Event Description
It was reported entrapment occurred.An opticross 6 hd was used during intravascular ultrasound of the right coronary artery (rca).When the physician attempted to remove the opticross 6 hd, it became stuck on the samurai wire that was in the patient.The physician was eventually able to remove both devices.There were no patient complications.
 
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Brand Name
OPTICROSS 6 HD
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol,
alajuela
CS  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8736702
MDR Text Key149260428
Report Number2134265-2019-07308
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8669
Device Catalogue Number8669
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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