MAUDE Adverse Event Report: ABBOTT MEDICAL DRAGONFLY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number OPTIS KIT

Device Problem Failure to Advance (2524)

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

Event Date 02/20/2020

Event Type  malfunction  

Event Description

Attempted to use dragonfly optis catheter but it would not advance through guiding catheter.Manufacturer response for dragonfly optis kit, dragonfly optis kit (per site reporter) pending.

• Brand Name: DRAGONFLY
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10319649
• MDR Text Key: 200229528
• Report Number: 10319649
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTIS KIT
• Device Catalogue Number: C408646
• Device Lot Number: 7167377
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1