FDA Adverse Event
Injury
Summary report: N
SUPERDIMENSION INREACH BRONCHUS SYSTEM
MDR report key: 3853060
·
Received May 23, 2014
Report
- Report Number
- 3004962788-2014-00032
- Event Type
- Injury
- Date Received
- May 23, 2014
- Date of Event
- April 29, 2014
- Report Date
- May 23, 2014
- Manufacturer
- SUPERDIMENSION, INC.
- Product Code
- JAK
- PMA / PMN Number
- K092365
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND WILL NOT BE RETURNED. THESE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. THE PHYSICIAN DOES NOT BELIEVE THIS OCCURRED DUE TO SUPERDIMENSION SYSTEM.
Description of Event or Problem · 1
THE SITE USED SUPERDIMENSION TO NAVIGATE TO THE LESION. THE SITE COULDN'T GET A DIAGNOSIS SO THEY WENT AHEAD WITH A LOBECTOMY WHICH RESULTED IN A THORACOTOMY, AND THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT WAS HOSPITALIZED AND HAS BEEN RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309133 | SUPERDIMENSION INREACH BRONCHUS SYSTEM | ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY | JAK | SUPERDIMENSION, INC. | AAS00161-12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| O| R |