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

Model Number	406103
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the introducer sideport detached approximately one to two days after placement in three separate patient events.The introducer had been placed in the jugular vein for the placement of a 5f temporary pacer while awaiting a permanent pacer.A pump set was connected and set to kvo.While in the icu, a day or two after introducer placement, the sideport disconnected.The introducer and the temporary pacer were removed and the scheduled pacer was placed.There were no adverse patient consequences reported.There were no reports of hard flushing or pulling on the iv tubing.
Additional Manufacturer Narrative
One 6f fast-cath introducer sheath was received for evaluation.The extension tubing had detached from the sideport of the hemostasis body due to an insufficient amount of solvent on the extension tubing.The root cause of this issue was determined to be consistent with a manufacturing issue.A corrective action was initiated to address the failure mode for insufficient amount of solvent applied to the stopcock tubing prior to insertion, resulting in sideport tubing detachment.This device was manufactured prior to the completion of the associated corrective action.

• 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: 19735813
• Report Number: 3005334138-2024-00284
• Device Sequence Number: 15547522
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: (01)05414734013772(10)10274538(17)270228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/05/2024

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: 406103
• Device Catalogue Number: 406103
• Device Lot Number: 10274538
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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
• Patient Sex: Unknown