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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 Entrapment of Device (1212)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event estimated based on notification date as no event date was provided.
 
Event or Problem Description
It was reported that a catheter stuck in stent occurred.Following implantation of a stent, the opticross imaging catheter was introduced for lesion visualization.During pullback of the catheter, the tip became stuck on the distal edge of the newly placed stent and the catheter was unable to be removed from the patient.No further information was able to be obtained.
 
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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 Key11642842
Report Number2134265-2021-04601
Device Sequence Number19623138
Product Code OBJ
UDI-Device Identifier08714729847878
UDI-Public08714729847878
Combination Product (Y/N)N
Initial Reporter StateNY
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) 04/09/2021
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 Date10/06/2021
Device Model Number8655
Device Catalogue Number8655
Device Lot Number0026141144
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/16/2021
Initial Report FDA Received Date04/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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