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

Model Number C407595

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Vascular Dissection (3160)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

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 dissection could not be conclusively determined.

Event Description

At the end of the interventional cerebral aneurysm embolization procedure, the guidewire was pushed out to pull out the vascular sheath and during the process, the guidewire punctured a blood vessel.Blood extravasation and subcutaneous congestion were noted.Compression and a vascular suture device were used to stabilize the patient.The guidewire was noted to be too hard.

• Brand Name: ULTIMUM HEMOSTASIS TRANSRADIAL KIT
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11169502
• MDR Text Key: 226776170
• Report Number: 3005334138-2020-00655
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734025690
• UDI-Public: 05414734025690
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: C407595
• Device Catalogue Number: C407595
• Device Lot Number: 7581918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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