MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 12; INTRODUCER, CATHETER

Model Number	406306
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the hub of the introducer separated from the shaft upon removal from the patient.The dislodgement occurred after the conclusion of the procedure with no excess force utilized.There were no patient consequences.
Additional Manufacturer Narrative
One 12f fast-cath trio introducer sheath was received for evaluation.The sheath tubing was returned loose and detached from the sheath hub.The sheath tubing had been flattened and torn at the proximal end; the sheath tear measure 0.07¿ in diameter.The sheath tubing had been bent in multiple locations.The sheath hub remained attached to the fast-cath trio hemostasis hub assembly.Dissection of the sheath hub and sheath tubing revealed all components of the sheath hub and sheath tubing were present and met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing detachment is consistent with damage during use.

• Brand Name: FAST-CATH TRIO HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 12
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11483587
• Report Number: 3005334138-2021-00176
• Device Sequence Number: 14305886
• Product Code: DYB
• UDI-Device Identifier: 05414734203920
• UDI-Public: 05414734203920
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 406306
• Device Catalogue Number: 406306
• Device Lot Number: 7425146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1