MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER

Model Number C407698

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

Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: an event of hemorrhaging and cardiac arrest 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 ultimum hemostasis introducer sheath instructions for use (ifu) instructs the user to insert the dilator into hemostasis valve and then follow normal accepted practice for vessel puncture, guidewire insertion, vessel dilator and hemostasis introducer use.The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations.The ultimum hemostasis introducer sheath instructions for use (ifu) states that prior to proceeding, verify the hemostasis introducer is of proper size to allow passage of desired catheter or other medical device.

Event Description

Patient lost blood pressure and had cardiac arrest after a tavi procedure with portico.The valve was successfully implanted and physicians were closing the access site in the femoral arteries when it became clear the patient had a large bleed by the femoral access point by unknown cause.It could be caused by removal of the ultimum ev hemostasis introducer, introducing of the closure device (manta) or the wire itself.They managed to stop the bleed by covered stents and the patient recovered well.Evaluation of the portico after resuscitation and patient recovery was working perfectly and the patient was hemodynamic stable.

• Brand Name: ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6981470
• MDR Text Key: 90384982
• Report Number: 3005334138-2017-00183
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K092575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: C407698
• Device Catalogue Number: C407698
• Device Lot Number: 5951579
• Other Device ID Number: 05415067009692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 84 YR