MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PHD; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number	00884450746714
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary bypass graft and recent chest pain.Procedure: left heart catheterization.The back end of the device is solid- there is no opening for wire to come out.No known harm to patient.Manufacturer response for adaptor, stopcock, manifold, fitting, cardiopulmonary bypass, phd (per site reporter), will obtain.

• Brand Name: PHD
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 20085016
• Report Number: 20085016
• Device Sequence Number: 7580762
• Product Code: DTL
• UDI-Device Identifier: 00884450746714
• UDI-Public: (01)00884450746714(17)270122(10)2834563
• 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): 07/30/2024
• Report Date (Section F): 07/30/2024

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: 00884450746714
• Device Catalogue Number: MAP800/B
• Device Lot Number: 2834563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Date Report Sent to FDA: 07/30/2024