MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. IMPRESS DIAGNOSTIC PERIPHERAL CATHETER

Catalog Number 1628-118

Device Problem Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2015

Event Type  Injury  

Event Description

The user reported that the top of the catheter became disconnected during use.The pt was moved to a hybrid operation room and tip was surgically removed by cutting into the vessel.No further harm or injury to the pt was reported.

Manufacturer Narrative

Device eval: the device has not been returned for eval.A f/u report will be sent when the eval has been completed.

• Brand Name: IMPRESS DIAGNOSTIC PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 w merit pkwy; s jordan, UT 84095 ; 8012084491
• MDR Report Key: 4774417
• MDR Text Key: 20733023
• Report Number: 3010665433-2015-00004
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 1628-118
• Device Lot Number: MN705295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention