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

Model Number C408645

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 10/31/2018

Event Type  Injury  

Event Description

When using the dragonfly optis catheter there difficulty was noted while positioning the device.The device continually prolapsed into a branch and caused a dissection.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported positioning issue and subsequent dissection could not be conclusively determined.

Event Description

When using the dragonfly optis catheter, there was an issue positioning the device.The device continually prolapsed into the obtuse marginal branch and caused a dissection.Once the catheter was removed, the vessel was reopened and the patient was fine.

Manufacturer Narrative

One dragonfly optis catheter was returned for investigation.The results of the investigation concluded that the catheter had been kinked between the lens and the guidewire exit port.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported positioning issue is consistent with the kink and the kink is consistent with damage during use.The cause of the dissection could not be conclusively determined.

• Brand Name: DRAGONFLY¿ OPTIS¿ CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 8062546
• MDR Text Key: 126901442
• Report Number: 3009600098-2018-00019
• Device Sequence Number: 1
• Product Code: DQO
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 6625427
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other