• 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 35 BOSTON SCIENTIFIC CORPORATION

  • 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 35 BOSTON SCIENTIFIC CORPORATION Back to Search Results
Model Number H7493932800350
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 08/31/2021
Event Type  No Answer Provided  
Event Description
Extensive thrombosed venous stent, ivus (intravascular ultrasound) catheter sheared off in stent/clot. Catheter portion that was broken was retrieved. Procedure finished without complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTICROSS 35
Type of DeviceBOSTON SCIENTIFIC CORPORATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12554123
MDR Text Key274056397
Report Number12554123
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493932800350
Device Catalogue NumberH7493932800350
Device Lot Number26604059
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2021
Event Location No Information
Date Report to Manufacturer09/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-