MAUDE Adverse Event Report: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C408646

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure, the device became perforated and contrast was leaking from the device.The procedure was completed with another device with no adverse patient consequences.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The syringe was also returned.Functional testing was not possible due to the presence of dried contrast within the catheter sheath; however, dimensional inspection revealed the purge hole diameter met the specifications.There were no anomalies, ruptures, or damages noted to the returned catheter.It should be noted that dragonfly optis models have a purge hole exit located proximal on the sheath to the purge hole exit port, which varies from earlier model dragonfly catheters where the purged liquid exits via the guidewire exit port.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 reported leak and perforation remains unknown.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10462884
• MDR Text Key: 204709422
• Report Number: 3009600098-2020-00019
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7351856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1