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

Model Number C408646

Device Problems Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem Vascular Dissection (3160)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

One dragonfly was returned to the manufacturer of analysis.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.The cause of the kink is consistent with damage during use.

Event Description

During the procedure there was a vessel dissection in the left main into the lad.There was difficulty tracking the tortuous vessel and was continuously buckling back on itself at the rx join.A stent was placed over the dissection, and another catheter was used to confirm the stent position.The patient remained stable throughout the procedure.

• Brand Name: DRAGONFLY OPTIS KIT BOX IMAGING 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: 9732281
• MDR Text Key: 188855745
• Report Number: 3009600098-2020-00003
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• 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
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7054334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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