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

Model Number C408646

Device Problem Difficult To Position (1467)

Patient Problem Aortic Dissection (2491)

Event Date 09/08/2015

Event Type  Injury  

Event Description

The physician attempted to view the distal end of a stent using a dragonfly optis catheter.He could not get the catheter into the desired position.The catheter was moved back and forth down the artery to reach the desired position but the catheter caused a dissection in the artery.The patient was monitored and given a troponin test.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation and the catheter batch number was not provided to perform a device history record review.A still oct image was provided that showed a vessel with a stent placement.No further information can be interpreted from the still image.Based on the information provided the investigation was limited and the investigation results are inconclusive.

• Brand Name: DRAGONFLY OPTIS KIT
• Type of Device: INTRAVASCULAR IMAGING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ST. JUDE MEDICAL; 4 robbins drive; westford MA 01886
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5118266
• MDR Text Key: 27294892
• Report Number: 3009600098-2015-00002
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/08/2015

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: Physician
• Device Expiration Date: 05/03/2017
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention