Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS HD; CATHETER, ULTRASOUND, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION OPTICROSS HD; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 8668
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 07/02/2020
Event Type  malfunction  
Event Description
It was reported that foreign material was observed.An opticross hd imaging catheter was selected for use to view the target lesion.During procedure, it was noted that presence of foreign object was found.The procedure was completed with different of same device.No patient complications were reported.
 
Event Description
It was reported that foreign material was observed.An opticross hd imaging catheter was selected for use to view the target lesion.During procedure, it was noted that presence of foreign object was found.The procedure was completed with different of same device.No patient complications were reported.
 
Manufacturer Narrative
The device was returned for analysis.No issues were found, the device appears to be in good conditions.It was not possible to observe any contamination on the device.The device was visually inspected under a microscope and no foreign object was observed in the device.No other issues or defects were observed during product analysis of the returned device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTICROSS HD
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10329369
MDR Text Key200605638
Report Number2134265-2020-09893
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/21/2021
Device Model Number8668
Device Catalogue Number8668
Device Lot Number0025446662
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Date Manufacturer Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-