MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-03-09 for SUPERTRAX NEEDLE-TIPPED CYTOLOGY BRUSH AKI00140-01 manufactured by Superdimension Inc..
[1922607]
A site reported after a superdimension case that the pt had a pneumothorax. It was further reported that the physician thought the needle brush used for biopsies may have been the cause but he was not sure. The pt was hospitalized and went home the next day. There was no allegation that the superdimension (sd) system caused or contributed to the pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
[9101045]
Pneumothorax is a known complication when a lung biopsy is performed during a transbronchial lung biopsy, or ct-guided percutaneous biopsy with complication rates up to approximately 27% with the ct guided procedure. Biopsy tools are designed to have sharp edges and their function is to puncture or otherwise penetrate the tissue in order to collect a specimen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004962788-2011-00008 |
| MDR Report Key | 2017349 |
| Report Source | 05,07 |
| Date Received | 2011-03-09 |
| Date of Report | 2011-03-09 |
| Date of Event | 2011-02-11 |
| Date Mfgr Received | 2011-02-11 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2011-03-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LEANN GREENBERG |
| Manufacturer Street | 161 CHESHIRE LANE NORTH SUITE 100 |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104083 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERTRAX NEEDLE-TIPPED CYTOLOGY BRUSH |
| Generic Name | CYTOLOGY BRUSH |
| Product Code | BTG |
| Date Received | 2011-03-09 |
| Catalog Number | AKI00140-01 |
| Lot Number | SD0910071 |
| Device Expiration Date | 2015-10-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUPERDIMENSION INC. |
| Manufacturer Address | 161 CHESHIRE LANE NORTH SUITE 100 MINNEAPOLIS MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-03-09 |