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

Model Number 00884450295922

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/13/2018

Event Type  Injury  

Event 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®
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• MDR Report Key: 7901397
• MDR Text Key: 121453923
• Report Number: 7901397
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450295922
• UDI-Public: (01)00884450295922
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 00884450295922
• Device Catalogue Number: 1628-241
• Device Lot Number: E1163827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 28835 DA