MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

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

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

An event of air embolism was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Additionally, no lot number was provided so a review of the device history record (dhr) was not possible.Based on the information received, the cause of the reported air embolism could not be conclusively determined.

Event Description

The following was published in the iranian heart journal, titled, "coronary and cerebral artery air embolism complicating trans-septal accessory pathway ablation." by hamid farzamnia, md et.Al.A (b)(6)-year-old woman presented with frequent episodes of paroxysmal palpitation and electrocardiographic evidence of minimal pre-excitation of the left lateral accessory pathway.The patient underwent septostomy, which revealed air bubbles in the left ventricular cavity.Aspiration was done with a pigtail catheter via the retrograde aortic approach.Transient st-elevation in the inferior leads was demonstrated.Left-sided hemiplegia was present after consciousness, which was completely resolved after 24 hours.

• Brand Name: AGILIS¿ INTRODUCER, UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9980848
• MDR Text Key: 189882393
• Report Number: 2182269-2020-00037
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/21/2020
• 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): Required Intervention
• Patient Age: 30 YR