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

Model Number	406103
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A piece of the introducer broke off in the patient requiring a snare for removal.On may 21st, v-a ecmo was introduced, with blood flow in the right femoral artery 16.5fr, blood outflow in the left femoral vein 21fr.The sheath was inserted in the right femoral vein to place a temporary pacing catheter for bradycardia.On may 28th, the blood inflow and outflow cannula was surgically removed following withdrawal from v-a ecmo.On may 29th, the sheath was removed while compressing the insertion site in order to remove the temporary pacing catheter.There was some resistance during removal, but the sheath was removed as is with doctor's judgement.When the sheath was checked after removal, it was found to have ruptured.The tip that remained may have been outside the blood vessel, so an incision was made near the insertion site, but it could not be confirmed.On may 30th, a ct scan confirmed that the remaining part was inside the blood vessel.On the same day, an 11fr sheath and snare were inserted in the right internal jugular vein and successfully removed the piece percutaneously.Since then, the patient has had severe anemia and has undergone frequent blood transfusions.After sheath removal, severe anemia persisted, so 8 units of rbc and 4 units of ffp were administered, and a subsequent ct scan confirmed a large hematoma in the retroperitoneum.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 6f fast-cath introducer sheath was received for evaluation.The sheath had been fractured and torn, consistent with the reported removal difficulty.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath damage and reported removal difficulty remains unknown.

• 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: 19591776
• Report Number: 3005334138-2024-00254
• Device Sequence Number: 8525156
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: (01)05414734013772(10)8418522(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 406103
• Device Catalogue Number: 406103
• Device Lot Number: 8418522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 09/14/2024
• Initial Report FDA Received Date: 06/23/2024
• Supplement Report FDA Received Date: 09/05/2024; 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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