MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 F; INTRODUCER, CATHETER

Model Number 406701

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2022

Event Type  Injury  

Event Description

Upon removal of the introducer, a portion of the device detached and remained in the patient when suturing the insertion site.The detached portion of sheath was noted on fluoroscopy.The site was re-accessed to allow for snare insertion and retrieval of the sheath portion which had migrated toward the right ventricular region.The snare was used to retrieve the detached portion with no apparent injury to the patient.

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 device detachment remains unknown.

Manufacturer Narrative

Corrected data: h2, h6.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 F
• Type of Device: 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: 15542651
• MDR Text Key: 301164729
• Report Number: 3005334138-2022-00543
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734216944
• UDI-Public: 05414734216944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 406701
• Device Catalogue Number: 406701
• Device Lot Number: 8458176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 119 KG