MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING TRANSSEPTAL NEEDLE KIT AND STYLET; TROCAR

Catalog Number	FND-019-05/CNB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a transeptal puncture procedure during an a-fib ablation procedure, the patient developed pericardial effusion.The procedure was cancelled and a pericardiocentesis procedure was successfully completed and the patient was transferred to the intensive care unit for recovery.
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 at a later date, the investigation will be re-opened.

• Brand Name: TRANSSEPTAL NEEDLE KIT AND STYLET
• Common Device Name: TROCAR
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15596570
• Report Number: 3010665433-2022-00105
• Device Sequence Number: 2265728
• Product Code: DRC
• UDI-Device Identifier: 00884450169742
• UDI-Public: 884450169742
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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-019-05/CNB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: INTERVENTIONAL GUIDWIRE; TRANSEPTAL CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown