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

Model Number 406143

Device Problem Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Recall number: 3005334138-12/5/2019-002-r.The investigation revealed that an 8f dilator and 8f sheath were packaged within the 8.5f fast-cath hemostasis introducer package.

Event Description

During the procedure, the catheter could not be passed through the sheath.Another package was opened but the catheter could not pass though the sheath again.The device was inspected and it was noted that the introducer was an 8fr introducer but the packaging indicated 8.5fr.The procedure was completed successfully with no adverse patient consequences without imaging.The devices used will not be returned as they were discarded at the hospital.An additional 26 units in total were found to contain 8f introducers in 8.5f packaging.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9508100
• MDR Text Key: 190805896
• Report Number: 3005334138-2019-00846
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734014212
• UDI-Public: 05414734014212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/20/2019

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: 02/28/2022
• Device Model Number: 406143
• Device Catalogue Number: 406143
• Device Lot Number: 6917183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1