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

Model Number C408646

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Event Description

The catheter was hot, and was soft at the catheter strain release point.

Manufacturer Narrative

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.

Event Description

During the procedure, after the catheter was prepared it was inserted into right the right coronary artery through the guide catheter and a cal 002 error popped up on the screen.Also, the device was found to be bent near the flushing point and it stopped working.The catheter appeared melted near the flushing point at catheter stain release point.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.A syringe was also returned.The results of the investigation revealed that the nitinol tube and optical fiber had been fractured, consistent with the reported issue; however, there were no kinks noted in the distal portion of the sheath.The ilumien system instruction for use (ifu), cautions that kinking and bending of the catheter can cause damage and that while connecting, ensure the proximal catheter segment is straight and aligned with the doc.The device history records were reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the nitinol tube and optical fiber fracture are consistent with damage during use.Based on the information received and condition of the returned device, the cause of the reported kink 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: 9514368
• MDR Text Key: 187097110
• Report Number: 3009600098-2019-00031
• 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,Followup,Followup
• Report Date: 07/24/2020

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: 12/03/2020
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 6742378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/26/2019; 02/25/2020; 07/08/2020
• Supplement Dates FDA Received: 01/13/2020; 03/03/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1