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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 8655
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/04/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a catheter break occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.An opticross us imaging catheter was introduced to view the target lesion.During withdrawal, the catheter broke and was removed using the guide extension catheter.No patient complications were reported and the procedure was completed successfully.
 
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Brand Name
OPTICROSS
Common Device Name
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11398698
Report Number2134265-2021-02615
Device Sequence Number14298248
Product Code OBJ
UDI-Device Identifier08714729847878
UDI-Public08714729847878
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K161125
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/02/2021
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
Operator of Device Health Professional
Device Expiration Date12/03/2021
Device Model Number8655
Device Catalogue Number8655
Device Lot Number0026462429
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/04/2021
Initial Report FDA Received Date03/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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