MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND PERICARDIOCENTESIS KIT.; CATHETER, IRRIGATION

Catalog Number	PC803EU/B
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a pericardiocentesis procedure, the drainage catheter could not be introduced into the patients pericardium.The distance between the drainage catheter tip and introducer was too large, so the drainage catheter could not be advanced through the access incision.The three-way stopcock outside the patient was too difficult to turn, it cracked/broke on the inside of the stopcock.The device was discarded at the account and will not be returned for evaluation.
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: PERICARDIOCENTESIS KIT.
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• Manufacturer Contact: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84084 ; 8012531600
• MDR Report Key: 20392836
• Report Number: 1125782-2024-00004
• Device Sequence Number: 12425120
• Product Code: GBX
• UDI-Device Identifier: 00884450013465
• UDI-Public: 884450013465
• 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): 09/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PC803EU/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown