MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO TRANSSEPTAL NEEDLE KIT AND STYLET..HEARTSPAN®

Catalog Number	FND-019-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that post transeptal puncture for a pulmonary vein isolation [pvi] procedure, a transesophageal echo [tee] was ordered to determine the cause of blood pressure changes in the patient.The tee accurately identified pericardial effusion/fluid collecting within the patient's pericardial sac.A pericardiocentesis was successfully performed to prevent cardiac tamponade for this patient.The bleeding could not be stopped in the further course of the procedure.Surgery was required.No additional patient complications to report.The device was discarded.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.

• Brand Name: TRANSSEPTAL NEEDLE KIT AND STYLET..HEARTSPAN®
• Common Device Name: TRANSSEPTAL NEEDLE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19943337
• Report Number: 3011642792-2024-00049
• Device Sequence Number: 14671854
• Product Code: DRC
• UDI-Device Identifier: 00884450630754
• UDI-Public: 884450630754
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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 Catalogue Number: FND-019-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEIWRE; TRANSEPTAL SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown