MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA DRAGONFLY OPTIS KIT BOX IMAGING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C408646

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  Injury  

Event Description

Manufacturing related ref: 3008452825-2019-00643, 3009600098-2019-00032.When attempting oct with the first catheter, the monitor showed a connection issue.A second catheter was used but the issue persisted.The doc was not working.The procedure was not able to be complete and was rescheduled.

Manufacturer Narrative

One dragonfly optis catheter was returned to the manufacturer for analysis.The results of the investigation concluded that an optical fiber fracture was detected at the lens, consistent with the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received and the condition of the returned device, the cause of the optical fiber fracture remains unknown.

• Brand Name: DRAGONFLY OPTIS KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9571539
• MDR Text Key: 174471522
• Report Number: 3008452825-2019-00642
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• PMA/PMN Number: K141453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7197219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; PIU2 C7XR
• Patient Outcome(s): Required Intervention