MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number 406107

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

An expired fast-cath introducer was used for transvenous pacemaker placement and the venous access detached from the introducer while the device was in the patient.All parts were successfully removed from the patient with no adverse consequences.

Manufacturer Narrative

The device was not returned for analysis; however, two images were returned.The images appear to show that the side-port tubing detached from the sheath hemostasis body while the sheath was inside the patient.It was also noted that fast-cath hemostasis introducer batch number 7308099 expired on november 30, 2022 which was prior to the reported event date of february 1, 2023.It was confirmed that this product was distributed prior to its expiration date.The cause of the use of expired product is consistent with user error.

• Brand Name: FAST-CATH HEMOSTASIS 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: 16405997
• MDR Text Key: 309996972
• Report Number: 3005334138-2023-00065
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734013819
• UDI-Public: 05414734013819
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K914090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 406107
• Device Catalogue Number: 406107
• Device Lot Number: 7308099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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