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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aneurysm (1708); Hemostasis (1895)

Event Date 01/01/2016

Event Type  Injury  

Event Description

According to an article ¿percutaneous carotid artery access in infants < 3 months of age," catheterization and cardiovascular interventions 87:757-761 (2016), a (b)(6) infant with pulmonary atresia intact ventricular septum underwent ductal stenting on day of life 6.A 4fr.Ultimum sheath was inserted into the carotid arteriotomy.Heparin 70 ¿ 100 u/kg was given to maintain activated clotting time of >200 seconds.A vascular ultrasound performed 12 hours post procedure showed a fistula involving the right carotid artery to internal jugular vein.Heparin was discontinued, aspirin initiated, and manual compression was applied, but was unsuccessful.The patient underwent surgery where no fistula was found but a pseudoaneurysm was identified and repaired.Doi: 10.1002/ccd.26310.

Manufacturer Narrative

Updated information revealed that the manufacturing site listed in this report is incorrect.The correct manufacturing site is st.Jude medical (b)(4).

• Brand Name: ULTIMUM INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7266244
• MDR Text Key: 99903190
• Report Number: 2182269-2018-00021
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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
• Date Manufacturer Received: 01/25/2018
• 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
• Treatment: HEPARIN (70-100 U/KG)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 DA
• Patient Weight: 3