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

Catalog Number 510038HH1

Device Problem Fracture (1260)

Patient Problems Calcium Deposits/Calcification (1758); Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

One suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The user reported that the tip of the catheter separated inside the patient.This occurred in the proximal right common iliac artery.There was calcification in the vessel.The tip was retrieved with a snare without further complications.

Manufacturer Narrative

Photographs of the suspect device were received for evaluation.The complaint is confirmed.The root cause is attributed to significant force applied to the fusezone.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.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 5870506
• MDR Text Key: 51921550
• Report Number: 3010665433-2016-00052
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 510038HH1
• Device Lot Number: E873457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• 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 Outcome(s): Required Intervention