FDA Adverse Event
Injury
Summary report: N
SUPERDIMENSION INREACH BRONCHUS SYSTEM
MDR report key: 3760907
·
Received April 9, 2014
Report
- Report Number
- 3004962788-2014-00024
- Event Type
- Injury
- Date Received
- April 9, 2014
- Date of Event
- March 13, 2014
- Report Date
- April 9, 2014
- Manufacturer
- SUPERDIMENSION, INC
- Product Code
- JAK
- PMA / PMN Number
- K092365
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUPERDIMENSION HAS REQUESTED DEVICES FROM THE SITE BUT HAS NOT COMPLETED EVALUATION TO DATE. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY.
Description of Event or Problem · 1
SITE REPORTED A PNEUMOTHORAX POST SUPERDIMENSION PROCEDURE. THE PT'S PNEUMOTHORAX WAS ENCOUNTERED AFTER THE PROCEDURE. PT RECEIVED A CHEST TUBE AND WAS HOSPITALIZED OVERNIGHT AND DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213278 | SUPERDIMENSION INREACH BRONCHUS SYSTEM | ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY | JAK | SUPERDIMENSION, INC | AAS00161-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization |