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

Model Number	406136
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a transcatheter aortic valve implantation (tavi) procedure, a blood leak was noted at the hemostasis valve after removal of the dilator.The device was not replaced, more blood was noted than if the valve functioned properly.There were no consequences to the patient,.
Additional 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 leak remains unknown.Corrected information: g1: additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 3005334138.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL (CVD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16263206
• Report Number: 2182269-2023-00003
• Device Sequence Number: 6066483
• Product Code: DYB
• UDI-Device Identifier: 05414734014137
• UDI-Public: 05414734014137
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: 06/30/2025
• Device Model Number: 406136
• Device Catalogue Number: 406136
• Device Lot Number: 8572085
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown