N
Patient 1
INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED.
MAUDE MDR 1320970
- MDR report key
- 1320970
- Report number
- 1721752-2009-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-01-22
- Date received
- 2009-02-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- GAIL HAPNER
- Address
- 15715 ARROW HWY IRWINDALE CA 91706 US
- Phone
- 909-909-9098
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-02-20 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE TIP OF A CATHETER USED DURING A VENTRICULAR TACHYCARDIA PROCEDURE WAS FOUND IN A FOLDED POSITION AND WAS NOT RESPONDING TO DEFLECTION AT THE POINT OF ATTEMPTING TO REMOVE THE CATHETER FROM THE PATIENT. WHEN CONSULTED, THE BIOSENSE WEBSTER REPRESENTATIVE SUGGESTED CUTTING THE HANDLE OF THE CATHETER TO RELEASE THE TENSION ON THE TIP, HOWEVER, IT DID NOT RESOLVE THE ISSUE. AORTIC DISSECTION HAD TO BE PERFORMED TO REMOVE THE CATHETER. STENT PLACEMENT WAS USED TO REPAIR THE DISSECTION. PATIENT'S CONDITION HAS IMPROVED. PROGNOSIS WAS SATISFACTORY. FURTHER INFORMATION RECEIVED MENTIONED THAT THE CASE WAS NOT AS SEVERE AS INITIALLY THOUGHT TO BE. UPON CUTTING THE HANDLE OF THE CATHETER TO RELEASE THE TENSION ON THE TIP, THE CATHETER DID NOT IMMEDIATELY BECOME UNFOLDED. AFTER APPROXIMATELY 5 MINUTES, THE CATHETER DID GO BACK TO A RELAXED POSITION. MEANWHILE, THE PHYSICIAN HAD ALREADY PERFORMED AN AORTIC DISSECTION AND CALLED FOR A SPECIALIST TO CONSULT AND PLACED THE STENT. THE INFORMATION PROVIDED MENTIONED THAT HAD THEY WAITED A LITTLE LONGER, THEY COULD HAVE RETRIEVED THE CATHETER WITHOUT HAVING TO PERFORM THE AORTIC DISSECTION AND STENTING.