MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PERCUTANEOUS SHEATH HAEMOSTASISS VALVE; HAEMOSTASIS VALVE

Model Number 680128

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is not returning for evaluation.The complaint cannot be confirmed.The root cause cannot be determined.A review of the device history and complaint database cannot be performed since the lot number was not provided.

Event Description

The account alleges that during an emergent st elevation myocardial infarction [stemi] intervention, requiring an emergent left & right heart hemodynamic evaluation for a patient in cardiogenic shock.A 5f temporary pacemaker wire would not advance through the valve of a 6f access sheath.The physician states that the fit was too tight and would not allow the pacing wire to advance through to the patient's vasculature to the targeted right ventricle.The physician quickly exchanged the sheath to successfully acquire access needed to place the temporary pacemaker for the patient.The patient was transferred post-procedure to icu for continued monitoring.

• Brand Name: PERCUTANEOUS SHEATH HAEMOSTASISS VALVE
• Type of Device: HAEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, ut ; 2084662
• MDR Report Key: 10403533
• MDR Text Key: 202886617
• Report Number: 8020616-2020-00041
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00886333601288
• UDI-Public: 00886333601288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 680128
• Device Catalogue Number: 680128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention