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

Catalog Number 59038UAC

Device Problem Kinked (1339)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return.A review of the device history record and complaint database is in progress and will be submitted upon completion.

Event Description

The account reported that while attempting to access the ipsilateral right uterine artery the catheter kinked in the abdominal aorta.The physician successfully advanced a hydrophilic guidewire through the kink after approximately 20 minutes.The physician expressed concern regarding the additional fluoro time used.Physician did not provide amount of fluoro used during the additional 20 minutes.No adverse consequences were reported as a result of this malfunction.

Manufacturer Narrative

The patient received an additional 40 minutes of flouro time.Device evaluation: because the unit was not returned, the root cause could not be determined.The complaint was unconfirmed.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.If the device is returned in the future this investigation will be reopened and a follow up submitted.

• 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: 5523590
• MDR Text Key: 41074633
• Report Number: 3010665433-2016-00014
• 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 Expiration Date: 10/31/2018
• Device Catalogue Number: 59038UAC
• Device Lot Number: E868257
• 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
• Patient Age: 35 YR