FDA Adverse Event Injury Summary report: N

SENSATION CATHETER

MDR report key: 19259305 · Received May 7, 2024

Report

Report Number
19259305
Event Type
Injury
Date Received
May 7, 2024
Date of Event
February 29, 2024
Report Date
April 29, 2024
Manufacturer
GETINGE
Product Code
DSP
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
AR, US
Reporter Occupation
RISK MANAGER
Health Professional
*

Narratives

Description of Event or Problem · 0

THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFTING X 3 ON (B)(6) 2024. THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS DURING SURGERY. DECREASED VENTRICULAR FUNCTION WAS NOTED. SHE WAS PLACED BACK ON CARDIOPULMONARY BYPASS. THE DECISION WAS MADE TO PLACE AN INTRA-AORTIC BALLOON PUMP. THE SURGEON ATTEMPTED TO PLACE THE BALLOON BY THE TRANSFEMORAL ROUTE ON THE LEFT SIDE BUT WAS UNABLE TO THREAD THE WIRE UP TO THE THORACIC AORTA. THE INTRA-AORTIC BALLOON PUMP WAS THEN PLACED VIA THE TRANSAORTIC ROUTE. VENTRICULAR PERFORMANCE IMPROVED. THE DECISION WAS MADE TO CONVERT TO ECMO SUPPORT. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE END OF SURGERY. IN THE AFTERNOON, BLOOD WAS NOTED IN THE HELIUM LINE, AND THE PATIENT'S HEMOGLOBIN WAS DECREASING. THE PATIENT WAS TAKEN EMERGENTLY BACK TO THE OR FOR MEDIASTINAL EXPLORATION AND CONTROL OF BLEEDING. THE BLEEDING WAS NOTED OVER THE AORTA. THE MAJOR BLEED WAS FOUND TO BE AROUND THE INSERTION SITE OF THE INTRA-AORTIC BALLOON PUMP. SUTURES WERE PLACED AROUND THE INSERTION SITE. BLEEDING WAS CONTROLLED. PRIOR TO TRANSFER, THE BALLOON WAS NOTED TO BE RUPTURED. THE DEVICE WAS CLAMPED AND UNHOOKED FROM THE PATIENT. SHE WAS TRANSFERRED TO (B)(6) HOSPITAL FOR FURTHER TREATMENT. THE PATIENT RECEIVED A TOTAL OF 87 UNITS OF BLOOD PRODUCTS. PLATELETS 55 X 10'3- (B)(6) 2024 THE PATIENT REQUIRED THE FOLLOWING BLOOD PRODUCTS: 17 UNITS RBC AS-3 LR, 5 UNITS RBC AS-1 LR/IR, 19 UNITS RBC AS-1 LR, 5 UNITS PLATELET PHER B, 3 UNITS PLATELETS PHER C, 22 UNITS THAWED CRYO, 5 UNITS PLATELET PHER, 11 UNITS THAWED FP 24 CPD. TOTAL UNITS- 87.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
530913 SENSATION CATHETER INTRA-AORTIC BALLOON PUMP DSP GETINGE

Patients

Seq Age Sex Outcome Treatment
1 60 YR Female ECMO| FEMORAL ARTERIAL LINE| RIGHT INTERNAL JUGULAR VEIN INTRODUCER SHEATH | RIGHT INTERNAL JUGULAR VEIN MULTI-LUMEN CATHETER| SWAN GANZ CATHETER| VENTILATOR