MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS 5FR RIM CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 00884450038185

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

5 fr rim catheter tip broke off catheter and stayed in patient iliac artery.Doctor retrieved catheter tip with snare device.No patient harm resulted.

• Brand Name: IMPRESS 5FR RIM CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 13341835
• MDR Text Key: 284360747
• Report Number: 13341835
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450038185
• Device Catalogue Number: 56535RIM
• Device Lot Number: E2089716
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male