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

Model Number 407843

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Foreign Body Embolism (4439)

Event Date 12/07/2021

Event Type  Injury  

Event Description

During the procedure, the introducer separated at the hub and a piece was left inside the femoral artery.The piece was retrieved successfully with a snare from the contralateral femoral artery.No complications were noted and there were no adverse consequences to the patient.

Manufacturer Narrative

One 5f ultimum introducer sheath was received for evaluation.The dilator was also returned.The reported event of sheath damage was confirmed.The sheath tubing had been torn and detached; the torn sheath tubing was returned.The cause of the sheath damage is consistent with damage during use.

Manufacturer Narrative

One 5f ultimum introducer sheath was received for evaluation.The dilator was also returned.The sheath tubing had been torn and detached at the hub; the torn sheath tubing was returned.The detached sheath tubing had been twisted, flattened, kinked and bent.The cause of the torn sheath tubing remains unknown.

• 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: 13012224
• MDR Text Key: 282330834
• Report Number: 3005334138-2021-00772
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 407843
• Device Catalogue Number: 407843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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