MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. - PEARLAND HEARTSPAN; CARDIAC TROCAR

Model Number	00884450412862
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the sheath was difficult to flush and draw back through the flush port.The sheath was replaced and the issue was resolved.It was also reported that the patient suffered a pericardial effusion.The account stated that they had done the transseptal and had mapped the left atrium when anesthesiology reported that the patient's blood pressure had dropped.A pericardial perfusion was confirmed using ice.The procedure was aborted and the effusion was being monitored.No intervention was planned.Patient was stable.No ablations had been performed.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: HEARTSPAN
• Common Device Name: CARDIAC TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. - PEARLAND; 14646 kirby drive; houston TX 77047
• MDR Report Key: 12333500
• Report Number: 3010665433-2021-00065
• Device Sequence Number: 2826130
• Product Code: DRC
• UDI-Device Identifier: 00884450412862
• UDI-Public: 00884450412862
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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 Expiration Date: 04/29/2023
• Device Model Number: 00884450412862
• Device Catalogue Number: FCL-201-01
• Device Lot Number: 1775937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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; Required Intervention