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

Model Number	680128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Cardiogenic Shock (2262)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.The physician attempted to acquire vascular access to the patient's right atrium with a thermodilution [td] catheter to acquire the pressures necessary to effectively evaluate right heart and lung function.The 7f td catheter would not fit thought the valve of the 8f access sheath.The inner lumen of the sheath was too tight, the physician could not acquire access to the patient's right heart chambers.The physician quickly exchanged the access sheath to successfully acquire heart and lung evaluations with the td catheter.The patient was transferred post-procedure to icu for continued monitoring.

• Brand Name: PERCUTANEOUS SHEATH HAEMOSTASISS VALVE
• Common Device Name: HAEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 10403541
• Report Number: 8020616-2020-00042
• Device Sequence Number: 2999775
• Product Code: DYB
• UDI-Device Identifier: 00886333601288
• UDI-Public: 00886333601288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 680128
• Device Catalogue Number: 680124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention