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

Model Number	406143
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9508104
• Report Number: 3005334138-2019-00983
• Device Sequence Number: 2981480
• Product Code: DYB
• UDI-Device Identifier: 05414734014212
• UDI-Public: 05414734014212
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: 02/28/2022
• Device Model Number: 406143
• Device Catalogue Number: 406143
• Device Lot Number: 6917183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• 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