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

Model Number	00884450009253
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Per the surgeon's explanation of event: the left axillary artery was exposed and a 12 fr sheath was placed.Through the 12 fr sheath a negare steerable sheath was placed and a 100 cm berenstein catheter was placed through it.I had to generate significant amount of torque on the sheath and it kinked.When i tried to remove the berenstein catheter the first 15-20 cm of catheter broke at the kink and stayed in the negare.The negare was removed with the catheter tip inside and passed off of the sterile field.

• Brand Name: IMPRESS
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 10835797
• Report Number: 10835797
• Device Sequence Number: 19731722
• Product Code: DQO
• UDI-Device Identifier: 00884450009253
• UDI-Public: (01)00884450009253(17)230707(10)E1870319
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450009253
• Device Catalogue Number: 510035BER
• Device Lot Number: E1870319
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 10/29/2020