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

Model Number	406183
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the joint between the sheath tube and sheath hub separated.Upon removal of the sheath from the patient and attempting to pull out the sheath from the right inguinal region, the joint between the sheath tube and sheath hub separated.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 10.5f fast-cath introducer sheath was received for evaluation.The sheath hemostasis hub had been detached from the sheath tubing.The proximal end of the sheath tubing had been stretched and fractured consistent with forcible contact.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the forcible contact remains unknown.
Event or Problem Description
The procedure was completed without replacing the introducer and there were no adverse consequences to the patient.

• 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: 15087004
• Report Number: 3005334138-2022-00430
• Device Sequence Number: 4814355
• Product Code: DYB
• UDI-Device Identifier: 05414734014458
• UDI-Public: 05414734014458
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/13/2023

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 Expiration Date: 12/31/2024
• Device Model Number: 406183
• Device Catalogue Number: 406183
• Device Lot Number: 8294377
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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
• Patient Sex: Unknown