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

Model Number 406772

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/14/2024

Event Type  Injury  

Event Description

During a myocardial biopsy as part of monitoring a heart transplant, the introducer remained blocked below the tricuspid vale when attempting to remove it.When it was finally removed, it was noted to be bent in two different places.There were no complications for the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 one 7f fast-cath introducer sheath was received for evaluation.The sheath had been bent and kinked in multiple locations.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bends and kinks is consistent with damage during use.The cause of the device entrapment could not be conclusively determined.

• 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: 19020837
• MDR Text Key: 339128298
• Report Number: 3005334138-2024-00122
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734012980
• UDI-Public: (01)05414734012980(10)9123697(17)260531
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 406772
• Device Lot Number: 9123697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2023
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Male