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

Model Number 406137

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

Arrived in the morning to the patient and introducer was leaking.Noticed the pillow was wet and the tubing of the catheter was disconnected.Rn was called to assess and staff both noticed the lumen of the catheter was dislodged.Team was immediately notified and they assessed.Decision to remove catheter was made as it could have been extremely dangerous for patient to get air via that catheter.Swan catheter which was connected was removed, pictures were taken and team was made aware.No patient harm.Manufacturer response for fast-cath hemostasis introducer (8.5fr), fast-cath hemostasis introducer (8.5fr) (per site reporter).Manufacturer is performing an investigation on units from 2 similar reported incidents in our medical center.The manufacturer also collected all our remaining shelf stock for that lot number for investigation.

• Brand Name: FAST-CATH¿
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 100 abbott park road; abbott park IL 60064
• MDR Report Key: 8424146
• MDR Text Key: 138909059
• Report Number: 8424146
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 6671878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1