MAUDE Adverse Event Report: ST. JUDE MEDICAL DRAGONFLY DUO IMAGING CATHETER; INTRAVASCULAR IMAGING CATHETER

Model Number	C408644
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of "patient's blood pressure dropped" and patient death 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 duo imaging catheter instructions for use (ifu) states that coronary artery spasm may occur as a consequence of intravascular imaging.The dragonfly duo imaging catheter instructions for use (ifu) states that abnormal heart arrhythmias may occur as a consequence of intravascular imaging.
Event or Problem Description
Pre-dilatation with a non-abbott balloon was performed in lad.Next, the dragonfly duo imaging catheter revealed a thrombus in lad.Additional stenting was performed with two non-abbott stents and follow up ballooning for stent malposition.The dragonfly duo imaging catheter was then used to assess lad and left main (lm).During this time, the patient's blood pressure dropped and the oct procedure was stopped.Cpr was initiated, medications were administered and the patient's blood pressure was revived back.The patient's pressure remained unchanged after 40-45 minutes of cpr and intra-aortic balloon pump (iabp) insertion.The patient passed away.The physician does not believe the oct caused the adverse events.

• Brand Name: DRAGONFLY DUO IMAGING CATHETER
• Common Device Name: INTRAVASCULAR IMAGING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 4 robbins drive; westford MA 01886
• MDR Report Key: 8013648
• Report Number: 3009600098-2018-00018
• Device Sequence Number: 1029817
• Product Code: ORD
• UDI-Device Identifier: 00183739000708
• UDI-Public: 00183739000708
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2019
• Device Model Number: C408644
• Device Catalogue Number: C408644
• Device Lot Number: 6193976
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 78 YR