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

Model Number	00884450160923
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	09/08/2021
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 customer reports that during an afib case, a pericardial effusion was noticed.After going transseptal catheter device was inserted into the body as the patient's blood pressure began to drop.Pericardial effusion was confirmed by ice when viewing the ventricular region.The medical intervention provided was a pericardiocentesis and 200 cc of fluid was removed.It was confirmed that the ablation catheter was not in the body and the transseptal catheter was not yet plugged in during transseptal.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: HEARTSPAN
• Common Device Name: TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 12585729
• Report Number: 3010665433-2021-00089
• Device Sequence Number: 11113269
• Product Code: DRC
• UDI-Device Identifier: 00884450160923
• UDI-Public: 00884450160923
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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 Model Number: 00884450160923
• Device Catalogue Number: FND-020-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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: Required Intervention