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 Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During transseptal puncture with a fast-cath transseptal introducer and non-abbott needle (medtronic) there was skiving.It was attempted to flush contrast through the non-abbott needle (medtronic) which was inside the fast-cath transseptal introducer against the septum, but the contract could not be flushed.The non-abbott needle (medtronic) was removed, and it was found that some of the fast-cath transseptal introducer material was clogging the needle tip.The fast-cath transseptal introducer and non-abbott needle (medtronic) needle were replaced and transseptal puncture was successful.
Additional Manufacturer Narrative
The procedure type was confirmed to be a wolff-parkinson-white syndrome procedure and it was also confirmed that the transseptal needle had been reshaped prior to use.
Event or Problem Description
During transseptal puncture of a wolff-parkinson-white syndrome procedure, with a fast-cath transseptal introducer and non-abbott needle (medtronic), that was reshaped, there was skiving.It was attempted to flush contrast through the needle which was inside the fast-cath transseptal introducer against the septum, but the contract could not be flushed.The needle was removed, and it was found that some of the fast-cath transseptal introducer material was clogging the needle tip.The fast-cath transseptal introducer and non-abbott needle (medtronic) needle were replaced and transseptal puncture was successful.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath was received for evaluation.No anomalies were noted when a brk needle/stylet assembly was advanced through the returned sheath/dilator assembly.The dilator was dissected and no evidence of skiving was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The brk transseptal needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the cause of the reported issue is consistent with not following the instructions for use.

• 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: 18971071
• Report Number: 3005334138-2024-00115
• Device Sequence Number: 6035790
• Product Code: DYB
• UDI-Device Identifier: 05414734203340
• UDI-Public: 05414734203340
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2024

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: 08/31/2026
• Device Model Number: 406840
• Device Lot Number: 9230007
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 04/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/23/2024; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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
• Patient Sex: Unknown