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

Model Number C408646

Device Problem Material Twisted/Bent (2981)

Patient Problem Vascular Dissection (3160)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After stent placement in the proximal left circumflex artery, a dissection occurred.During oct imaging for post stent assessment the catheter was attempted to be positioned, but it could not pass through the stent.The device was kinked after the monorail proximal of the stent in the vessel.The catheter was re-positioned but the issue persisted, so the device was removed from the patient¿s anatomy.The tip was inspected and found to be kinked.After removing the catheter, angio was performed to check the vessel and a dissection was discovered proximal of the first implanted stent where the device was kinked.A second stent was placed to cover the dissection.No optical coherence tomography was done.The patient is stable.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The results of the investigation concluded that there were kinks between the lens and guidewire exit port, consistent with the reported event.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.The cause of the kink 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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8876594
• MDR Text Key: 153789256
• Report Number: 3008452825-2019-00397
• 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
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: C408646
• Device Lot Number: 6964433
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention