MAUDE Adverse Event Report: BOSTON SCIENTIFIC OPTICROSS; CORONARY IMAGING CATHETER

Catalog Number H7495188110

Device Problems Failure to Cycle (1142); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  Other  

Event Description

Opticross coronary imaging catheter would not "spin" when plugged into motor drive, a second catheter was tried with same issue, a third catheter was obtained and it worked, unable to troubleshoot if this was a product issue, or motor drive issue.Motor drive service completed.Diagnosis or reason for use: diagnostic heart catheterization.

• Brand Name: OPTICROSS
• Type of Device: CORONARY IMAGING CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA
• MDR Report Key: 5875171
• MDR Text Key: 52221794
• Report Number: MW5064066
• Device Sequence Number: 1
• Product Code: OBJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: H7495188110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR