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

Catalog Number 51103810PIG-NB

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.A follow up will be submitted when evaluation is complete.

Event Description

The account reports that during a thoracic endovascular aortic repair (tevar) procedure, the catheter tip dislodged within the brachial artery sheath when trying to introduce the catheter into the artery.The physician noted that the catheter would not pass through the sheath and when removing the catheter from the sheath the tip separated and remained inside the 6f sheath.

Manufacturer Narrative

One device was returned for evaluation.The device was visually examined and the complaint was confirmed.The root cause was significant force applied to the fusezone junction prior to the catheter tip tubing pulling apart from the remainder of the device.The device history record was reviewed and no exception documents were found.The complaint data base was reviewed and no similar complaints for the lot number were found.

• Brand Name: IMPRESS DIAGNOSTIC CATHETER
• Type of Device: DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes ms, cqe ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6180670
• MDR Text Key: 62680702
• Report Number: 3010665433-2016-00071
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 51103810PIG-NB
• Device Lot Number: E926168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2016
• 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