PERICARDIOCENTESIS KIT.
Received Oct 22, 2024 · Event occurred Oct 14, 2024
Report 1125782-2024-00005 · MDR key 20511136
Device
Generic name
Fluid Drainage Tray
Manufacturer
Merit Medical RichmondCatalog number
PC101/B
Lot number
T2876373
Product problems
- Material Too Rigid or Stiff
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
- Material Too Rigid or Stiff
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
Patient
82 YR · Male
- Angina
- Arrhythmia
- Cardiac Arrest
- Exsanguination
- Hemorrhage/Blood Loss/Bleeding
- Ischemia
- Perforation
- Pleural Effusion
- Cardiac Tamponade
- Discomfort
- Cardiac Perforation
- Angina
- Arrhythmia
- Cardiac Arrest
- Exsanguination
- Hemorrhage/Blood Loss/Bleeding
- Ischemia
- Perforation
- Pleural Effusion
- Cardiac Tamponade
- Discomfort
- Cardiac Perforation
Narrative
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.
Description of Event or Problem
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.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.
Description of Event or Problem
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.