D
Patient 1
AORTIC VALVE REPLACEMENT WITH SUBSEQUENT USE OF ABLATION SYSTEM. DURING THE PLACEMENT OF THE ABLATION CATHETER, THERE WAS A PERFORATION ON THE LEFT ATRIUM THROUGH A SHARP, BENT ELECTRODE.
MAUDE MDR 3912929
- MDR report key
- 3912929
- Report number
- 2953686-2014-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-05-02
- Date received
- 2014-06-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- INNETTA WALKER
- Address
- 2603 CAMINO RAMON STE 100 SAN RAMON CA 94583 US
- Phone
- 925-925-9258
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COBRA FUSION 150 ABLATION SYSTEM | COBRA FUSION 150 ABLATION SYSTEM | ENDOSCOPIC TECHNOLOGIES | OCL | 700-001S | 700-001S | 12948-120213 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-06-10 | 0 | 1. R |
Event Narratives#
N
Patient 1
MANUFACTURER HAS REQUESTED THE DEVICE BACK FROM THE HEALTHCARE FACILITY. DEVICE HISTORY RECORDS WERE REVIEWED. PICTURE OF DEVICE SENT TO MANUFACTURER WAS REVIEWED AND SHOWED EXTREME MANIPULATION WHERE THE COMPONENT ASSEMBLY WAS TORN. INSTRUCTION FOR USE INSTRUCTS THE USER ONLY TO GRASP AT THE DISTAL OR PROXIMAL ENDS, AWAY FROM THE ELECTRODES.