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

Model Number 406124

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

While removing the catheters post procedure from the groin, the fast-cath hemostasis introducer ripped.Part of the device was still in the patient but able to be removed because the catheter was still in the patient.

Manufacturer Narrative

Product evaluation: the reported event of "the fast-cath hemostasis introducer ripped" could not be confirmed.The results of the investigation are inconclusive since the device was not received in the product performance engineering lab 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.The fast-cath introducer instructions for use (ifu) cautions the user to not attempt to advance or withdraw guidewire if resistance is felt.Use fluoroscopy to determine cause.The fast-cath introducers instructions for use (ifu) recommends the user advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7608457
• MDR Text Key: 111450777
• Report Number: 3005334138-2018-00164
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734014052
• UDI-Public: 05414734014052
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2020
• Device Model Number: 406124
• Device Catalogue Number: 406124
• Device Lot Number: 6288956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 49