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

Model Number C408646

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 06/20/2018

Event Type  Injury  

Event Description

The dragonfly optis catheter was advanced into the vessel and past the area of interest.A second pullback was performed as the first pullback had inadequate clearance of the lumen.After the second pullback an angio acquisition showed a spiral dissection starting at the sensor marker of the device.Allegedly, the dissection may have been caused by the rotation of the sensor against the vulnerable soft plaque deposits on the vessel wall.The dragonfly optis catheter had no visible damage and the sensor was intact after removal from the patient.The procedure was completed without oct.Access to patient identifiers is unavailable.

Manufacturer Narrative

An event of dissection was reported.The results of the investigation concluded that no functional anomalies were noted during pullbacks; there was no excess movement of the sheath or torque-wire during imaging.A 0.014¿ guidewire was able to be inserted through the tip of the catheter and out the guidewire exit port with no anomalies.Dimensional analysis revealed that the outside diameter of the transition between the sheath and the window tube and the outside diameter of the window tube met the specifications.The image submitted with the returned device shows three angiograms; however, the event could not be confirmed through the photo.The device history records for each possible batch number (6324045 and 6353989) were reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.The dragonfly optis instructions for use states the user should always advance and withdraw the catheter slowly.Failure to observe device movement fluoroscopically may result in vessel injury or device damage.To assure proper placement do not move the guide wire after the dragonfly duo imaging catheter is in place.The dragonfly optis instructions for use states that if resistance is encountered during advancement or withdrawal of the dragonfly duo imaging catheter, stop manipulation and evaluate under fluoroscopy.If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.The dragonfly optis instructions for use states the user should always verify that the catheter has been properly prepared prior to inserting into vasculature.The dragonfly optis instructions for use states the following complications may occur as a consequence of intravascular imaging: coronary artery spasm, unstable angina, allergic reaction to the contrast media, arterial dissection, injury or perforation, thrombus formation, abrupt closure, or total occlusion, abnormal heart arrhythmias, embolism, acute myocardial infarction, death.

Manufacturer Narrative

An event of a spiral dissection and a positioning issue was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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 incident could not be conclusively determined.The dragonfly optis imaging catheter instructions for use (ifu) states that the user should observe all advancement and movement of the dragonfly optis imaging catheter under fluoroscopy.Always advance and withdraw the catheter slowly.Failure to observe device movement fluoroscopically may result in vessel injury or device damage.To assure proper placement do not move the guide wire after the dragonfly optis imaging catheter is in place.The dragonfly optis imaging catheter ifu states that is resistance is encountered during advancement or withdrawl of the dragonfly optis imaging catheter, stop manipulation and evaluate under fluoroscopy.If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.The dragonfly optis imaging catheter ifu states that arterial dissection is a possible complication that may occur as a consequence of intravascular imaging.

• Brand Name: DRAGONFLY OPTIS KIT BOX IMAGING CATHETER
• Type of Device: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 7677609
• MDR Text Key: 113674356
• Report Number: 3009600098-2018-00014
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• PMA/PMN Number: K150878
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 6324045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other