MAUDE Adverse Event Report: LIGHTLAB IMAGING,INC. DRAGONFLY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number OPTIS¿ KIT

Device Problems Device Alarm System (1012); Break (1069)

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

Event Date 01/29/2020

Event Type  malfunction  

Event Description

During a heart catheterization, an optical coherence tomography measurement was to be obtained.While setting up the optical coherence tomography catheter, an error appeared that stated optical coherence tomography catheter damaged, please remove from body.Catheter removed and another catheter was used without difficulty manufacturer response for imaging catheter, dragonfly optis kit (per site reporter) clinical rep will be in to evaluate.

• Brand Name: DRAGONFLY
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): LIGHTLAB IMAGING,INC.; 4 robbins rd; wastford MA 01886
• MDR Report Key: 9670655
• MDR Text Key: 177778162
• Report Number: 9670655
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTIS¿ KIT
• Device Catalogue Number: C408646
• Device Lot Number: 7167997
• 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: 01/29/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA