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

Model Number C408646

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 11/20/2019

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 pre-dilation of the proximal right coronary artery, a dissection occurred.A stent had previously been placed in the same location prior to optical coherence tomography.The event was resolved without sequelae.

Manufacturer Narrative

Correction to the initial report, additional information was received that the dissection occurred prior to the use of the dragonfly catheter and was caused by a non-abbott balloon.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10725896
• MDR Text Key: 212705038
• Report Number: 3009600098-2020-00026
• 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: 11/19/2020

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: 06/04/2020
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 6460741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 106