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

Model Number	406787
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an endomyocardial biopsy procedure, a piece of the sheath detached requiring surgery for removal.The sheath was inserted in the right ventricle and an endomyocardial biopsy was performed using the sheath without difficulty.After this, a 0.035 j wire was placed in the sheath, the sheath was pulled down to the iliac vein and then the femoral vein.At the groin, tension was noted on the sheath.The sheath was removed with a moderate amount of force.The distal 6mm of the sheath, broke off as the sheath and wire were removed.It was unclear whether the detached portion of the sheath was intravascular or embedded in the subcutaneous tissue.A cutdown procedure was performed with manipulation of the femoral vessel and the sheath tip embolized to the left upper lung lobe.
Event or Problem Description
During an endomyocardial biopsy procedure, a piece of the sheath detached requiring surgery for removal.The sheath was inserted in the right ventricle and an endomyocardial biopsy was performed using the sheath without difficulty.After this, a 0.035 j wire was placed in the sheath, the sheath was pulled down to the iliac vein and then the femoral vein.At the groin, tension was noted on the sheath.The sheath was removed with a moderate amount of force.The distal 6mm of the sheath, broke off as the sheath and wire were removed.It was unclear whether the detached portion of the sheath was intravascular or embedded in the subcutaneous tissue.A cutdown procedure was performed with manipulation of the femoral vessel and the sheath tip embolized to the distal segment left upper lung lobe.It was decided to leave the sheath tip in place rather than remove it.There have been no issues or complications for the patient.
Additional Manufacturer Narrative
One 7f fast-cath introducer sheath and dilator were received for evaluation.The distal end of the sheath was fractured and detached.The distal portion of the sheath was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported removal difficulty could not be conclusively determined due to the returned condition of the device.The sheath damage is consistent with damage during use.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20091265
• Report Number: 3005334138-2024-00357
• Device Sequence Number: 7810477
• Product Code: DYB
• UDI-Device Identifier: 05414734011778
• UDI-Public: (01)05414734011778(10)10241817(17)270228
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 406787
• Device Catalogue Number: 406787
• Device Lot Number: 10241817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 10/17/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown