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 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, a significant delay occurred.An error message appeared after the catheter was connected to the system.The device was reattempted three times, but the issue persisted and the procedure was delayed.Another device was used to complete the procedure with no patient consequences.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.A hoop was also returned.The results of the investigation concluded that an optical fiber fracture was detected at the splice region of the catheter shaft, consistent with the reported connection issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the condition of the returned device and the information received, 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: 8898844
• MDR Text Key: 154527711
• Report Number: 3008452825-2019-00415
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: C408646
• Device Lot Number: 6971141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR