MAUDE Adverse Event Report: ABBOTT LABORATORIES DRAGONFLY OPTIS IMAGING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number C408645

Device Problem Failure to Sense (1559)

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

Event Date 01/02/2018

Event Type  malfunction  

Event Description

Post stenting physician was using imaging catheter to ensure stent apposition in lad; imaging catheter didn't sense contrast 2 different times.Catheter was removed and procedure completed.

• Brand Name: DRAGONFLY OPTIS IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ABBOTT LABORATORIES; westford MA 01886
• MDR Report Key: 8222286
• MDR Text Key: 132523883
• Report Number: MW5082875
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654
• Combination Product (y/n): N
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: C408645
• Device Lot Number: 6491109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR