MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN DRAGONFLY; DIAGNOSTIC INTRAVASCULAR CATHETER

Catalog Number UNK DRAGONFLY

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

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 09/16/2019

Event Type  Death  

Manufacturer Narrative

The udi number is ¿ni¿ as the catalog number was not provided.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during the procedure the dragonfly imaging catheter was inserted into the patient however a large quantity of air was accidentally injected into the patient¿s heart and the patient went into cardiac arrest.Cpr was performed however the patient died.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The device history record (dhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the case information, there was no conclusive cause(s) for the reported patient effects, and their respective relationship to the product, if any, that could be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.

• Brand Name: UNKNOWN DRAGONFLY
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15092350
• MDR Text Key: 296460540
• Report Number: 2024168-2022-08078
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK DRAGONFLY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death