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

Model Number	406962
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
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 reported incident could not be conclusively determined.
Event or Problem Description
During the procedure after the puncture, the triple-hemostasis valves and sheath were not connected properly, it was not straight.Three 5fr sheaths were used to complete the procedure instead and there were no adverse consequences to the patient.Three additional access sites were required for the replacement devices due to the malfunction.Further information regarding the event is pending.
Event or Problem Description
The connection between the triple valves part and the sheath was not straight.There was no detachment of the device component noted.

• Brand Name: FAST-CATH TRIO HEMOSTATIS INTRODUCER CATH-LOCK INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10184503
• Report Number: 3005334138-2020-00226
• Device Sequence Number: 10990191
• Product Code: DYB
• UDI-Device Identifier: 05414734204040
• UDI-Public: 05414734204040
• 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,Followup
• Report Date (Section B): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 406962
• Device Catalogue Number: 406962
• Device Lot Number: 7002749
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other