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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 Problems Entrapment of Device (1212); Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2020
Event Type  malfunction  
Event Description
It was reported that catheter entanglement occurred. An opticross imaging catheter was selected for use on the severly calcified lesion. It was noted that during the procedure, lost image had occurred during pullback because the tip of the catheter got caught on the edge of the stent and the screen became black. The procedure was completed with another of the same device. No patient complications were reported.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10283986
MDR Text Key199109018
Report Number2134265-2020-09373
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2022
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0025314271
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2020
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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