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

Model Number C408646

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

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, after the device was pulled back and the image was completed, and pulled out from the patient's anatomy, a small plastic seam was noted.The doctor believed that the small plastic seam piece was from the distal tip of the catheter.Another catheter was used to complete the procedure and the patient was stable.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The syringe was also returned.Four (4) photos and two (2) videos were submitted for evaluation.The media submitted appeared to show a thin, strand-like foreign material (fm) at the distal end of the catheter.There were no visual anomalies or foreign materials noted on or with the returned component; however, four photos and two videos were returned and reviewed.Review of the submitted media revealed a fm at the distal end of the device, which is consistent with the reported event.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 event could not be conclusively determined.

• 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: 10184961
• MDR Text Key: 197137806
• Report Number: 3009600098-2020-00016
• 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: 07/15/2020

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: 12/28/2021
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7319696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/23/2020
• 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 Age: 71 YR