MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH GUIDING INTRODUCER SWARTZSR0; INTRODUCER, CATHETER

Model Number	406844
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a cryo-pulmonary vein isolation procedure, during transseptal puncture, it was noticed that the sheath became punctured.The device was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath and dilator were received for evaluation. the sheath and dilator had been punctured proximal to the distal tip.Functional testing with a brk needle was not performed because the complaint introducer is a swartz right sided (sr series) guiding introducer dilator, not a transseptal introducer dilator.For transseptal access with a brk needle, swartz left sided (sl series) transseptal guiding introducers are recommended.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the puncture is consistent with the incorrect use of the device.

• Brand Name: FAST-CATH GUIDING INTRODUCER SWARTZSR0
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12149100
• Report Number: 3005334138-2021-00421
• Device Sequence Number: 17087483
• Product Code: DYB
• UDI-Device Identifier: 05414734202930
• UDI-Public: 05414734202930
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 12/31/2023
• Device Model Number: 406844
• Device Catalogue Number: 406844
• Device Lot Number: 7804989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1