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

Model Number 406962

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

Event Type  Injury  

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 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 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10184503
• MDR Text Key: 196098255
• Report Number: 3005334138-2020-00226
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734204040
• UDI-Public: 05414734204040
• Combination Product (y/n): N
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other