MAUDE Adverse Event Report: ST. JUDE MEDICAL HYDROSTEER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number 405061

Device Problem Positioning Problem (3009)

Patient Problem Hematoma (1884)

Event Date 01/08/2018

Event Type  Injury  

Event Description

When using the hydrosteer guidewire there was resistance felt while advancing.The tip caused a vessel perforation proximal to the fistula and therefore causing a hematoma, which was then treated non-surgically with direct pressure applied for 45 minutes and dressing applying pressure for 24 hours.The device had trouble making a turn in the anatomy.Tortuosity was reported.

Manufacturer Narrative

Updated information revealed that the manufacturing site listed in this report is incorrect.The correct manufacturing site is st.Jude medical plymouth, facility registration number is (b)(4).

Manufacturer Narrative

Product evaluation: an event of "hematoma" was reported.The reported event of a positioning issue could not be confirmed.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 incident could not be conclusively determined.

• Brand Name: HYDROSTEER GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7230789
• MDR Text Key: 98669490
• Report Number: 2182269-2018-00017
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Model Number: 405061
• Device Catalogue Number: 405061
• Device Lot Number: 9915520
• Other Device ID Number: (10)9915520(17)200930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• 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