MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406840
Medical Device Problem Codes	Material Frayed (1262); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3008452825-2024-00403.During an atrial tachycardia procedure, deflection and insertion difficulties were noted which caused a delay in procedure.Following insertion into the patient, the introducer would not rotate and the auto lock did not function.Another introducer was then inserted into the patient with some resistance.Upon removal from the patient, it was noted that the tip was frayed.A third introducer was then used to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath and dilator were received for evaluation.Visual inspection revealed the sheath tip had been split.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tip damage and subsequent delay could not be conclusively determined.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE
• 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: 19756404
• Report Number: 3005334138-2024-00304
• Device Sequence Number: 12980468
• Product Code: DYB
• UDI-Device Identifier: 05414734203340
• UDI-Public: (01)05414734203340(10)9183615(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/30/2024

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: 07/31/2026
• Device Model Number: 406840
• Device Catalogue Number: 406840
• Device Lot Number: 9183615
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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: AGILIS¿ NXT STEERABLE INTRODUCER
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG