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

Model Number	406114
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the side port of the sheath detached.There is no additional information available at this time.
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.
Additional Manufacturer Narrative
Additional information: d4, d9, g3, h2, h3, h4, h6, h11.One 8f fast-cath introducer was received open still within its sterile packaging.An event of sideport detachment was reported.Pull testing confirmed that the device met specifications during pull testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: INTRODUCER FASTCATH
• 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: 20561701
• Report Number: 3005334138-2024-00459
• Device Sequence Number: 8865744
• Product Code: DYB
• UDI-Device Identifier: 05414734013932
• UDI-Public: (01)05414734013932(10)10465562(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 406114
• Device Catalogue Number: 406114
• Device Lot Number: 10465562
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FAST-CATH HEMOSTASIS INTRODUCER; FAST-CATH HEMOSTASIS INTRODUCER; FAST-CATH HEMOSTASIS INTRODUCER
• Patient Sex: Unknown