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

Model Number C408646

Device Problems No Display/Image (1183); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Event Description

Oct catheter was unable to image, removed from sterile field, and replaced with a new one, never entered patient.

• Brand Name: DRAGONFLY¿
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd; westford MA 01886
• MDR Report Key: 12512244
• MDR Text Key: 272690302
• Report Number: 12512244
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7943690
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1