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

Lot Number K2337333

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Description

The device should allow the arterial pressure to be continuously monitored through the guiding catheter.Arterial pressure readings are frequently dampened while using this device.This is raising safety concerns because physicians rely on the pressure waveforms to indicate that they are not obstructing blood flow in the coronary artery.Since the waveforms are frequently dampened with this device, the physicians are concerned that they are performing procedures in a less safe environment.

• Brand Name: MBA HEMOSTASIS VALVE
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 14103154
• MDR Text Key: 289317818
• Report Number: MW5108933
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: K2337333
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 31 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian