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
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
16jan20 additional report required for received date.

• Brand Name: FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 14
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9507808
• Report Number: 3005334138-2019-00971
• Device Sequence Number: 2079880
• Product Code: DYB
• UDI-Device Identifier: 05414734203906
• UDI-Public: 05414734203906
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 01/21/2020

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: 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
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/03/2020; 01/03/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/20/2020; 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1