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

Model Number 406103

Device Problems Material Separation (1562); No Apparent Adverse Event (3189)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

Post procedure, when attempting to remove the sheath from the patient, a portion of the sheath detached and remained in the patient.The detached portion was retrieved from the patient before migrating further in the body.

Manufacturer Narrative

After further information was received and review it was confirmed that this event is a duplicate of per-2023-0093693 and has already been reported under regulatory report mdr-2023-26004.

Event Description

After further information was received and review it was confirmed that this event is a duplicate of per-2023-0093693 and has already been reported under regulatory report mdr-2023-26004.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• 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: 17328044
• MDR Text Key: 319680373
• Report Number: 3005334138-2023-00316
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: 05414734013772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 406103
• Device Catalogue Number: 406103
• Device Lot Number: 8799559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention