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

Model Number 406568

Device Problems Fracture (1260); Kinked (1339); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medwatch number: mw5067798.Product evaluation: the results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.The fast-cath 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 instructions for use (ifu) recommends the user advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.

Event Description

A 6f fast-cath hemostasis introducer sheath was inserted into the right femoral artery during an angiogram.Towards the end of the procedure, the catheter was unable to be exchanged and it was noticed that the sheath was kinked and had a crack in it.It was reported that this may have been caused by kink and torqueing of the catheter.Intervention was required.

• 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: 6415250
• MDR Text Key: 70300144
• Report Number: 3005334138-2017-00023
• Device Sequence Number: 1
• Product Code: DYB
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 406568
• Device Catalogue Number: 406568
• Device Lot Number: 5410242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• 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): Required Intervention