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

Model Number C408646

Device Problem Vibration (1674)

Patient Problem Occlusion (1984)

Event Date 06/24/2019

Event Type  Injury  

Event Description

The catheter occluded the vessel and caused patient discomfort.The device was connected to the doc normally during device preparation.After advancing the catheter to the lad lesion the catheter started vibrating.The catheter was disconnected and re-attached to the doc.The vibration occluded the lad and caused patient discomfort and chest pain.The catheter was then removed from the artery and the pci procedure was completed without using oct or other imaging techniques with no patient consequences.

Manufacturer Narrative

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

Event Description

The catheter occluded the vessel and caused patient discomfort.The device was connected to the doc normally during device preparation.After advancing the catheter to the lad lesion the catheter started vibrating.The catheter was disconnected and re-attached to the doc.The vibration occluded the lad and caused patient discomfort and chest pain.The occlusion was diagnosed with normal use of fluoroscopy, contrast, and x-ray imaging.The catheter was then removed from the artery and the pci procedure was completed without using oct or other imaging techniques with no patient consequences.

Manufacturer Narrative

One dragonfly optis catheter was returned to the manufacturer for analysis.The results of the investigation concluded that the catheter had been bent inside the strain relief.The catheter was able to be connected and there was anomalous movement noted during live-view mode, which is consistent with the reported event.Dimensional inspection revealed that the sheath to window transition met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event is consistent with the bend.The cause of the bend is consistent with damage during use.

• 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: 8754524
• MDR Text Key: 149831740
• Report Number: 3009600098-2019-00015
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: C408646
• Device Lot Number: 7021880
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other