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

Catalog Number 59038UAC

Device Problem Kinked (1339)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and a follow up submitted.Since the lot number was not provided, the device history record and complaint database could not be reviewed.

Event Description

The physician reported that while attempting to access the ipsilateral right uterine artery the catheter kinked in the abdominal aorta.The physician expressed concern regarding additional fluoro time used to resolve the kink.Physician did not provide amount of excess fluoro used.No adverse consequences were reported as a result of this malfunction.

Manufacturer Narrative

It was originally reported that the physician expressed concern regarding additional fluoro time used to resolve the kink.The physician stated that no extra fluoro time was necessary.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 5523606
• MDR Text Key: 41074431
• Report Number: 3010665433-2016-00016
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053171
• 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
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 59038UAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• 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