MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 14; INTRODUCER, CATHETER

Model Number 406303

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Recall number: 3005334138-12/5/2019-001-r.The investigation revealed that a 12f dilator and 12f sheath were packaged within the 14f fast-cath trio hemostasis introducer package.

Event Description

After a procedure the customer decided to return 129 unused devices for continued insertion difficulties.It was later determined that the introducers were 12f instead of the 14f as labeled.

Manufacturer Narrative

16jan20 additional report required for received date.

• Brand Name: FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 14
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9507808
• MDR Text Key: 190767491
• Report Number: 3005334138-2019-00971
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203906
• UDI-Public: 05414734203906
• 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,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 406303
• Device Catalogue Number: 406303
• Device Lot Number: 7133555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1