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

Model Number	00884450295922
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came to hospital for a procedure to coil an endoleak of an endovascular abdominal aortic aneurysm.The patient had femoral access.The surgeon introduced the vanschie 5 catheter over a wire and was positioning the catheter to reach the leaking point.Under fluoroscopy he noticed the wire was not out the end of the catheter.He pulled catheter and wire out of the patient and the tip of the catheter sailed downstream and rested on the sheath that was in the left groin.The patient then required general anesthesia and a femoral cutdown to retrieve the catheter tip.The tip was retrieved.The patient remained in the icu for 48 hours for observation.The intended procedure was aborted.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• MDR Report Key: 7901397
• Report Number: 7901397
• Device Sequence Number: 10805268
• Product Code: DQO
• UDI-Device Identifier: 00884450295922
• UDI-Public: (01)00884450295922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/17/2018
• Report Date (Section F): 09/17/2018

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
• Operator of Device: Health Professional
• Device Model Number: 00884450295922
• Device Catalogue Number: 1628-241
• Device Lot Number: E1163827
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Date Report Sent to FDA: 09/17/2018