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

Model Number	406948
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, a sheath detachment occurred.The sheath was inserted into the left atrium and a non abbott device (jll-rebero 15mm catheter) was inserted into the sheath.Approximately 2 hours later, a sense of incongruity was noted in the transmission of torque while operating the non abbott catheter and the sheath detached from the hub.The sheath was not replaced as the detachment occurred when checking the potential of the on abbott catheter.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Health effect - impact code updated to 4613 - minor injury/ illness / impairment due to no intervention during or after the procedure.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath was received for evaluation.Visual inspection revealed the hemostasis hub of the introducer was detached from the sheath tubing.Both the sheath tubing and inner hemostasis hub had an irregular shape.Abbott in continuing to monitor this issue.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15796795
• Report Number: 3005334138-2022-00626
• Device Sequence Number: 19995883
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: 05414734203531
• 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,Followup
• Report Date (Section B): 07/31/2023

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: 02/28/2025
• Device Model Number: 406948
• Device Catalogue Number: 406948
• Device Lot Number: 8384224
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 03/31/2023; 07/28/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 04/03/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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