MAUDE Adverse Event Report: MERIT MEDICAL IMPRESS ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 56538KA2

Device Problems Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  Injury  

Event Description

Patient came to the hospital for a scheduled outpatient procedure.Patient underwent an ultrasound-guided right av fistulogram which revealed stenosis within the venous limb of the av fistula.Using a balloon, angioplasty was performed.During the procedure, the tip of the catheter broke off and then the shaft of the catheter migrated to the level of the left pulmonary artery.The interventional radiologist was able to retrieve the entire catheter fragment using a loop snare.The patient tolerated the procedure, had a successful outcome, and was discharged home later in the day.

• Brand Name: IMPRESS ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL
• MDR Report Key: 8305553
• MDR Text Key: 135585420
• Report Number: MW5083681
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 56538KA2
• Device Lot Number: E1468840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 52