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

Catalog Number 512535HH1

Device Problem Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2015

Event Type  Injury  

Event Description

The user reported that during a diagnostic procedure, the tip of the catheter disconnected.The tip of the catheter was removed from the abdominal aorta using a snare.No further harm or injury to the patient was reported.

Manufacturer Narrative

Device evaluation.The device has not returned for evaluation.A follow up report will be sent when the evaluation has been completed.

• Brand Name: IMPRESS DIAGNOSTIC PERIPHERAL CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 4701451
• MDR Text Key: 22151003
• Report Number: 1628221-2015-00003
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 512535HH1
• Device Lot Number: E355954
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention