MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER; Introducer, catheter

Model Number 407845

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

During a percutaneous coronary intervention procedure, it was noted that there was a hole in the sheath.The sheath was exchanged and the procedure was completed with no adverse consequences to the patient.At the end of the procedure, exoseal was about to be performed when the closure device would not advance.The sheath was exchanged and upon removal a hole was observed.It is unknown if this occurred when the exoseal was being introduced or at some other point.The procedure was completed with the replacement introducer with no adverse consequences to the patient.It is noted that the affected sheath inserted without issue and the right common femoral artery angiogram looked good.

Manufacturer Narrative

The device was not returned for analysis; however, an image related to the complaint was returned.The image shows the dilator protruding out of a hole in the sheath.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.

• Brand Name: ULTIMUM 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: 18874162
• MDR Text Key: 337310363
• Report Number: 3005334138-2024-00069
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734011075
• UDI-Public: 05414734011075
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407845
• Device Lot Number: 9122700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1