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

Model Number C408641

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During a percutaneous coronary intervention procedure, a perforation occurred when using the catheter in a lad#6 lesion with vessel tortuosity and moderate stenosis.A rotablator was used and then the catheter was advanced.The catheter was difficult to advance and became kinked when advancing the device into the lesion.A perforation was noted around lad#5 on the cine image and an occlusion occurred.Two graftmasters were used and the procedure moved on to two vessel coronary artery bypass surgery.The patient was stable.

Manufacturer Narrative

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

Event Description

During a percutaneous coronary intervention procedure, a perforation occurred when using the catheter in a left circumflex artery lesion with vessel tortuosity and moderate stenosis.A rotablator was used and then the catheter was advanced.The catheter was difficult to advance and became kinked when advancing the device into the lesion.A perforation was noted around lad#5 on the cine image and an occlusion occurred.Two graftmasters were used and the procedure moved on to two vessel coronary artery bypass surgery.

• Brand Name: DRAGONFLY OPTIS CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9683937
• MDR Text Key: 188860747
• Report Number: 3009600098-2020-00002
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: C408641
• Device Lot Number: 7106195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• 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