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

Model Number	406962
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a paroxysmal supraventricular tachycardia procedure, the trio adapter was detached when the sheath was connected and flushed before insertion into the patient.After reconnecting and inserting the sheath into the vein, the trio adapter detached again while inserting the inquiry catheter (ibi-81251).The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 10.5f fast-cath trio introducer sheath was received for evaluation.The sheath was able to screw into place normally and stay attached during manipulation.The sheath was able to be flushed normally with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported detachment remains unknown.

• Brand Name: FAST-CATH TRIO¿ HEMOSTASIS INTRODUCER CATH-LOCK¿ 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: 19168889
• Report Number: 3005334138-2024-00156
• Device Sequence Number: 7349427
• Product Code: DYB
• UDI-Device Identifier: 05414734204040
• UDI-Public: (01)05414734204040(10)8356403(17)250131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061015
• 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): 07/02/2024

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 Expiration Date: 01/31/2025
• Device Model Number: 406962
• Device Catalogue Number: 406962
• Device Lot Number: 8356403
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2022
• 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: Male