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

Catalog Number 565352HK0-8

Device Problem Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/21/2015

Event Type  Injury  

Event Description

The user reported that while the wire and catheter were in a bifurcation, the physician moved the catheter back over the amplatz wire and the tip of the catheter separated from the shaft.The tip was removed with a snare.No further harm or injury to the pt was reported.Two lot numbers were provided for this complaint.No info was provided indicating which lot is related to this complaint.

Manufacturer Narrative

Add'l lot info: lot no: e758835, exp date: 02/28/2018.Add'l lot info: device manufacture date: 03/2015.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.; s jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 w merit pkwy; s jordan, UT 84095 ; 8012084491
• MDR Report Key: 4774415
• MDR Text Key: 18091581
• Report Number: 1628221-2015-00004
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/21/2015

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: 08/31/2017
• Device Catalogue Number: 565352HK0-8
• Device Lot Number: E680436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention