MAUDE Adverse Event Report: ST. JUDE MEDICAL ENGAGE TR INTRODUCER; INTRODUCER, CATHETER

Model Number C408536

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The following was published in the cardiovascular revascularization medicine in an article titled "distal versus traditional radial approach for coronary angiography", michael koutouzis, accepted 28 september 2018.The study included two hundred patients to evaluate the distal radial (dr) and the traditional radial (tr) artery puncture sites in terms of efficacy and safety.The patients were scheduled to undergo trans radial coronary angiography in two different greek hospitals were enrolled in this study.Inclusion was performed between april and june 2018.Review of the study revealed an occlusion, hematoma and vascular spasm.

Event Description

Per the physician, the engage tr, introducer did not cause the occlusion, hematoma or vascular spasm.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the physician, the engage tr, introducer did not cause the occlusion, hematoma or vascular spasm.

Manufacturer Narrative

Additional information: d1, d4.

• Brand Name: ENGAGE TR INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16621880
• MDR Text Key: 312103061
• Report Number: 3005334138-2023-00121
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K093130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C408536
• Device Catalogue Number: C408536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Other