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	Difficult to Insert (1316); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the transseptal needle punctured through the introducer while inserted into the patient.Initially it was noted that difficulty was encountered while inserting the needle through the introducer.A stylet was not used with the needle.A new needle was used, but the same issue occurred.The introducer was then removed from the patient and a puncture was noted.The introducer was replaced and the procedure was able to be continued and completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath and dilator were received for evaluation.The dilator and sheath were flushed with fluid and the dilator was inserted into the sheath.A brk needle/stylet assembly from current inventory was inserted and successfully advanced through the entire length of the dilator/sheath assembly with no resistance or functional anomalies noted.The damage is consistent with a failure to use a stylet/similar component during needle insertion.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the needle insertion difficulty and perforation is consistent with not following the instructions for use.
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
During the procedure, the transseptal needle punctured through the introducer while inserted into the patient.Initially it was noted that difficulty was encountered while inserting the needle through the introducer.A stylet was not used with the needle and the needle was pre-shaped.A new needle was used, but the same issue occurred.The introducer was then removed from the patient and a puncture was noted.The introducer was replaced and the procedure was able to be continued and completed with no adverse consequences to the patient.

• 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: 13506189
• Report Number: 3005334138-2022-00071
• Device Sequence Number: 4073139
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: 05414734203531
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/25/2022

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: 06/30/2024
• Device Model Number: 406948
• Device Catalogue Number: 406948
• Device Lot Number: 8056620
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 02/04/2022; 03/10/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 02/16/2022; 03/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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