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

Model Number	406804
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During transseptal puncture, resistance was noted when the needle, without the stylet, was advanced through the sheath.The needle was removed and a small piece of plastic was noted on the needle.A new needle and sheath were used to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer dilator were received for evaluation.The brk needle was also received.No visual anomalies were noted.No resistance was noted when inserting the returned needle with stylet from current inventory through the returned dilator.The dilator tubing was cut lengthwise and a build-up of skived material was noted at the distal end of the dilator.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported complaint is consistent with the failure to use a stylet/similar component during needle insertion through the dilator.The ifu states, ¿during insertion, always use the stylet to facilitate needle passage through the dilator/sheath assembly.(failure to use the stylet may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly or skiving of material from the inner surface of the dilator).¿.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8199328
• Report Number: 3005334138-2018-00522
• Device Sequence Number: 11187274
• Product Code: DYB
• UDI-Device Identifier: 05414734203302
• UDI-Public: 05414734203302
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K920327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 04/30/2021
• Device Model Number: 406804
• Device Catalogue Number: 406804
• Device Lot Number: 6459268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1