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

Model Number	406955
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the resistance and subsequent additional puncture could not be conclusively determined.
Event or Problem Description
During a procedure, resistance was noted when inserting the introducer and the dilator assembly into the femoral vein.Upon removal of the device, cracks were noted at the tip of the dilator.It was noted there was a gap between the dilator and the tip of the introducer transition zone, and incompatibility with the guidewire and the dilator.Three additional punctures and three replacement introducers were required to complete the procedure with no adverse consequences to the patient.

• Brand Name: FAST-CATH TRIO HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10407962
• Report Number: 3005334138-2020-00357
• Device Sequence Number: 3257045
• Product Code: DYB
• UDI-Device Identifier: 05414734203999
• UDI-Public: 05414734203999
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

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: 09/30/2021
• Device Model Number: 406955
• Device Catalogue Number: 406955
• Device Lot Number: 6691594
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1