MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-08-19 for SUPERTRAX TRIPLE NEEDLE TIPPED CYTOLOGY BRUSH SDTNB1500 manufactured by Superdimension Inc..
[21167556]
A component of te superdimension system; case recordings, were returned and evaluated. The evaluation resulted in no problem found. The issue was not verified in lab; therefore, no conclusion could be made. There were no anomalies identified during the internal review of the dhr of the system console. The lot number for the triple needle cytology brush was not provided by the site therefore no internal review was conducted. If add'l info is rec'd a f/u report will be submitted. Pneumothorax is a known short term complication when a lung biopsy or ct guided percutaneous biopsy.
Patient Sequence No: 1, Text Type: N, H10
[21179116]
The patient suffered a pneumothorax during a superdimension procedure. The patient rec'd a chest tube and was hospitalized. If add'l info pertinent to the incident is obtained a f/u report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[72693372]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004962788-2014-00043 |
| MDR Report Key | 4039995 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-19 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-07-22 |
| Date Mfgr Received | 2014-07-22 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 161 CHESHIRE LANE NORTH SUITE 100 |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERTRAX TRIPLE NEEDLE TIPPED CYTOLOGY BRUSH |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2014-08-19 |
| Returned To Mfg | 2014-07-28 |
| Model Number | SDTNB1500 |
| Catalog Number | SDTNB1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUPERDIMENSION INC. |
| Manufacturer Address | 161 CHESHIRE LANE NORTH MINNEAPOLIS MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2014-08-19 |