MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND PERICARDIOCENTESIS KIT.; FLUID DRAINAGE TRAY

Catalog Number	PC101/B
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Arrhythmia (1721); Cardiac Arrest (1762); Exsanguination (1841); Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942); Perforation (2001); Pleural Effusion (2010); Cardiac Tamponade (2226); Discomfort (2330); Cardiac Perforation (2513)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that an emergency pericardiocentesis procedure was required on a male patient, due to an interventional guidewire perforation at the distal circumflex artery, during a percutaneous coronary intervention procedure.The alleged distal cx perforation was treated but, the patient continued to show signs of a pericardial effusion that led to hemopericardium and cardiac tamponade.The patient underwent an emergent thoracotomy where the pericardiocentesis drainage catheter was identified at the inferolateral wall of the patient's left ventricle.The patient later expired despite all attempts to treat this patient.
Additional Manufacturer Narrative
Additional information to include: *** section a: patient info received/updated.Section b: [x] alleged product problem checked.Section b5 - additional information updated.Corrections: section b: event date changed to oct 14th 2024.Section b.2 event / patient death date changed to: (b)(6) 2024.Code a updated to replace 2993 and include 1544, 1670.Code g updated to include: 3038.
Event or Problem Description
The guidewire in use during pci that led to the pericardial effusion was an.014 w /hydrophilic tip.The physician states that due to the the stiffness and curve of the pc drainage catheter, the pc catheter also contributed to the laceration of the pericardium.Pericardial access was via the subxiphoid technique, under us guidance.Procedural access was via the right radial artery and the patient's time of death was 6:00 pm on (b)(6) 2024.
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.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: PERICARDIOCENTESIS KIT.
• Common Device Name: FLUID DRAINAGE TRAY
• 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: 20511136
• Report Number: 1125782-2024-00005
• Device Sequence Number: 7045046
• Product Code: PXU
• UDI-Device Identifier: 00884450015278
• UDI-Public: 884450015278
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup,Followup
• Report Date (Section B): 10/16/2024

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: PC101/B
• Device Lot Number: T2876373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 11/15/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/05/2024; 11/19/2024
• 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: ASAHI SION BLACK .014 W /HYDROPHILIC TIP.; INTERVENTIONAL BALLOON; INTERVENTIONAL GUIDWIRE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Male