MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE IDEAL; INTRODUCER, CATHETER

Model Number	10884450381868
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A (b)(6) years old patient with a history of hypertension, diabetes mellitus, and cirrhosis was admitted with a new onset of chest pain.In the catheterization laboratory, a diagnostic cath was going to be performed when the tip of a prelude ideal¿ vascular catheter introduction set broke when attempting to insert the dilator into the sheath.The broken piece was noticed by one of the health care providers.Moreover, as seen in the attached images, the broken piece caused the device to have a jagged edge.The faulty prelude ideal¿ vascular catheter introduction set was not used on the patient.
Event or Problem Description
A 49-years old patient with a history of hypertension, diabetes mellitus, and cirrhosis was admitted with a new onset of chest pain.In the catheterization laboratory, a diagnostic cath was going to be performed when the tip of a prelude ideal¿ vascular catheter introduction set broke when attempting to insert the dilator into the sheath.The broken piece was noticed by one of the health care providers.Moreover, as seen in the attached images, the broken piece caused the device to have a jagged edge.The faulty prelude ideal¿ vascular catheter introduction set was not used on the patient.

• Brand Name: PRELUDE IDEAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 11601753
• Report Number: 11601753
• Device Sequence Number: 11586092
• Product Code: DYB
• UDI-Device Identifier: 00884450381861
• UDI-Public: (01)00884450381861(17)230930(10)H2032401
• 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,Followup
• Report Date (Section B): 03/29/2021
• Report Date (Section F): 03/29/2021

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: 10884450381868
• Device Catalogue Number: PID6F11021SSC/A
• Device Lot Number: H2032401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 98
• Date Report Sent to FDA: 03/29/2021