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

Model Number	406137
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
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 sideport detachment could not be conclusively determined.
Event or Problem Description
During the procedure, the sideport of the introducer detached.The device was exchanged and the issue was resolved.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Three images were submitted for evaluation and the device was not returned.The extension tubing had detached from the sideport of the hemostasis body due to an insufficient amount of solvent on the extension tubing.Visual inspection was based solely upon a review of the photographs and video provided.
Additional Manufacturer Narrative
Corrected data: b3 (event date unknown), h6, h10.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 incident could not be conclusively determined.

• 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: 11375938
• Report Number: 3005334138-2021-00104
• Device Sequence Number: 3781487
• Product Code: DYB
• UDI-Device Identifier: 05414734012751
• UDI-Public: (01)05414734012751(10)7462611(17)230228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2021

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: 02/28/2023
• Device Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 7462611
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/26/2021; 04/22/2021; 04/29/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/29/2021; 04/26/2021; 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 26