FDA Adverse Event
Injury
Summary report: N
ACHIEVE MAPPING CATHETER
MDR report key: 2250519
·
Received September 16, 2011
Report
- Report Number
- 3007798852-2011-00004
- Event Type
- Injury
- Date Received
- September 16, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 19, 2011
- Manufacturer
- MEDTRONIC ABLATION FRONTIERS
- Product Code
- DRF
- PMA / PMN Number
- K102588
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IT WAS DISCARDED AFTER THE PROCEDURE SINCE NO MALFUNCTION OCCURRED DURING THE PROCEDURE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
AT THE END OF THE CRYOABLATION PROCEDURE, THE PATIENT COUGHED UP BLOOD. THE PHYSICIAN ADMINISTERED PROTAMINE TO THE PATIENT. THE CT SHOWED BLOOD INFILTRATION IN THE LUNG FROM THE RSPV. AS PER THE PHYSICIAN, THE RSPV WAS VERY SMALL WITH SEVERAL BRANCHES AND THE PERFORATION OCCURRED DURING MANIPULATION OF THE ACHIEVE MAPPING CATHETER. AFTER THE FIRST AID MEASURES THE PATIENT WAS IN GOOD CONDITION AND WAS DISCHARGED FROM THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACHIEVE MAPPING CATHETER | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | MEDTRONIC ABLATION FRONTIERS | 990063-015 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |