MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH GUIDING INTRODUCER SWARTZ SR SERIES, SR0 8.5F; INTRODUCER, CATHETER

Model Number	406853
Medical Device Problem Codes	Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath and dilator were received for evaluation.The sheath had been punctured 0.17¿ from the distal tip.The sheath tubing had been kinked 8.88¿ from the distal tip; the sheath distal tip had been split and the distal end had been flattened.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath puncture is consistent with the incorrect use of the device.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a punctured sheath.

• Brand Name: FAST-CATH GUIDING INTRODUCER SWARTZ SR SERIES, SR0 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12032172
• Report Number: 3005334138-2021-00403
• Device Sequence Number: 19875208
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 06/21/2021

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: 406853
• Device Catalogue Number: 406853
• Device Lot Number: 7804994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1