MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERICARDIOCENTESIS KIT; PERICARDIOCENTESIS CATHETER KIT

Model Number	PC803EU/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.
Event or Problem Description
The account alleges that at the end of a cryotherapy procedure for ablation of paroxysmal atrial fibrillation, the patient was unresponsive to simple commands.The clinical team suspected cardiac tamponade.Cpr was administered and the patient was intubated.Two attempts to perform a pericardiocentesis were attempted by the attending physician.First attempt: pericardial puncture is unsuccessfully attempted with the 18g pink needle.The practitioner states that the needle may be clogged; it was impossible to pull back on the plunger of the syringe.Second attempt: pericardial puncture is attempted with a pink spinocan 18gg 88mm needle reference 4501390 from bbraun.This attempt was successful, and the procedure was completed with 90 ml's of blood removed from the patient's pericardial sack.The same syringe was used with both needles.The patient's vital signs improved.

• Brand Name: PERICARDIOCENTESIS KIT
• Common Device Name: PERICARDIOCENTESIS CATHETER KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17399140
• Report Number: 9616662-2023-00010
• Device Sequence Number: 7657502
• Product Code: PXU
• UDI-Device Identifier: 00884450013465
• UDI-Public: 00884450013465
• Combination Product (Y/N): N
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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: PC803EU/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/26/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown