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

Model Number	406112
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the device was inserted from the right groin to the femoral vein.Following removal of the dilator, the cannula was swollen in two places.Another device was used and inserted through an additional puncture site to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath was received for evaluation.The sheath had been kinked.No dilator damage was noted.The sheath was flushed with fluid and the dilator was inserted and successfully advanced through the entire length of the sheath assembly and removed with no resistance or functional anomalies noted.No gap or visual anomalies were noted at the dilator/sheath transition.The dilator was flushed with fluid and the returned guidewire was inserted and successfully advanced through the entire length of the dilator with no resistance or functional anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported insertion difficulties and subsequent device replacement could not be determined.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15231872
• Report Number: 3005334138-2022-00472
• Device Sequence Number: 4899519
• Product Code: DYB
• UDI-Device Identifier: 05414734013918
• UDI-Public: 05414734013918
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 09/30/2024
• Device Model Number: 406112
• Device Catalogue Number: 406112
• Device Lot Number: 8188922
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown