MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 35; BOSTON SCIENTIFIC CORPORATION

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.

• Brand Name: OPTICROSS 35
• Type of Device: BOSTON SCIENTIFIC CORPORATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12554123
• MDR Text Key: 274056397
• Report Number: 12554123
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 26604059
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2021
• Date Report to Manufacturer: 09/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1