MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7 F; INTRODUCER, CATHETER

Model Number	406702
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, a portion of sheath detached in the patient.The patient is stable.
Event or Problem Description
During the procedure, a portion of sheath detached in the patient and a snare was use to retrieve the detached portion.The sheath was introduced into the vein on the patient¿s left groin site.A cs catheter was then introduced through that sheath.Approximately 20minutes later, it was noted that the hub and the tubular part of the sheath had disconnected.The hub portion was outside of the patients body and the tubular portion had migrated forward past the patients skin and into the vessel itself.Once this was noticed, approximately 1-2hrs were spent trying to remove the tubular portion of the sheath from the patient.Two snares were placed through an agilis, through an 18f sheath, on the right groin to retrieve the detached portion of the sheath after removal of the detached tubular portion of the sheath, pressure was held at the original access site to make sure there was no bleed back and the decision was made to continue the case.The patient is in stable condition.
Additional Manufacturer Narrative
One 7f fast-cath cath-lock introducer sheath was received for evaluation.Visual inspection revealed the sheath hub had been detached from the sheath tubing; the sheath tubing proximal end had been fractured.The sleeve remained attached to the hub.The sheath had been bent 1.60¿ proximal to the distal tip.The reported issue is consistent with ep luer sheath hub detachment issues.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7 F
• Common Device Name: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16023005
• Report Number: 3005334138-2022-00701
• Device Sequence Number: 17891935
• Product Code: DYB
• UDI-Device Identifier: 05414734216951
• UDI-Public: 05414734216951
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 406702
• Device Catalogue Number: 406702
• Device Lot Number: 8660415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown