inforMED
DeathNKQ

BOSTON SCIENTIFIC

Received Dec 9, 2015 · Event occurred Nov 13, 2015

Report 5292459 · MDR key 5292459

Device

Generic name

Mod Support Straight Tip Guidewire

Model number

PT2 GUIDEWIRE

Catalog number

H74938931030

Lot number

18464862

Product problems

  • Material Fragmentation

Patient

74 YR

  • Right Ventricular Failure
  • Cardiac Tamponade
  • Cardiac Perforation

Narrative

Description of Event or Problem

(B)(6) MALE PRESENTS WITH ABNORMAL STRESS MYOVIEW FOR ELECTIVE CARDIAC CATHETERIZATION AND PERCUTANEOUS CORONARY INTERVENTION. DISTAL WIRE FRACTURE NOTED AFTER STENT DEPLOYMENT WITH SIGNIFICANT PERICARDIAL "BLUSH". ECHO POST PROCEDURE REVEALED SIGNIFICANT PERICARDIAL BLOOD WITH TAMPONADE. PATIENT TAKEN EMERGENTLY TO CVOR FOR PERICARDIAL WINDOW. RIGHT VENTRICLE FAILED DURING PROCEDURE AND PT DEVELOPED CARDIAC ARREST. PT EXPIRED DESPITE AGGRESSIVE ACLS MEASURES. GUIDEWIRE 1.7CM SHORTER WITH SLIGHT CURVATURE AT END WHEN MEASURED AND COMPARED TO A NEW INTACT WIRE. NOTIFICATION ON 12/04/2015 TO (B)(4), BOSTON SCIENTIFIC CORONARY REPRESENTATIVE (B)(4), NOTIFICATION FORWARDED TO SCIENTIFIC COMPLAINTS DEPT (B)(4).