MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿; INTRODUCER, CATHETER

Model Number	406844
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One fast-cath introducer sheath and dilator were received for evaluation.The device was returned due to insertion difficulty of a transseptal needle.The needle insertion difficulty was due to using a brk needle with a right sided guiding introducer dilator, not a transseptal introducer dilator as recommended.During functional testing, the dilator was flushed and a brk needle/stylet assembly was inserted but the needle was unable to exit the sheath assembly.The dilator tubing was cut length-wise and build-up of foreign material was noted at the tip of the dilator.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the brk needle insertion difficulties is consistent with the incorrect use of the device, the cause of the foreign material remains unknown.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a foreign material within the sr0 guiding introducer dilator.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8717910
• Report Number: 3005334138-2019-00325
• Device Sequence Number: 13892379
• Product Code: DYB
• UDI-Device Identifier: 05414734202930
• UDI-Public: 05414734202930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: 06/30/2021
• Device Model Number: 406844
• Device Lot Number: 6539439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1