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

Model Number C408646

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The dragonfly catheter broke off in the rca vessel.The device was removed as one unit off the wire and the procedure was finished with a stent placement and no patient consequences.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.A hoop and the syringe were also returned.The results of the investigation concluded that there were no anomalies, damages, or fractures noted to the returned catheter.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 event remains unknown.

• Brand Name: DRAGONFLY OPTIS KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 10078516
• MDR Text Key: 191731967
• Report Number: 3009600098-2020-00011
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

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: 01/28/2022
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7351838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention