MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-03-31 for SUPERTRAXTRIPLE NEEDLE BRUSH manufactured by Superdimension Inc..
[41521652]
The device was not returned for evaluation. The lot numbers for the triple needle brush and the gencut biopsy tool are unknown therefore no investigation or dhr review can be performed. Bleeding is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy. If additional information is received a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[41521653]
The patient experienced bleeding from the lul during a superdimension procedure. If additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[49047993]
Patient Sequence No: 1, Text Type: N, H10
[49047994]
The site reported that the patient experienced 30 cc of bleeding that was treated with saline, epinephrine, and lidocaine. The bleeding is reported to have occurred following vigorous brushings with the supertrax triple needle brush. The right lower lobe was not biopsied as the patient became hypoxic. If additional information pertinent to the incident is obtained another follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2016-00071 |
| MDR Report Key | 5537471 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-31 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-01-05 |
| Date Mfgr Received | 2016-03-04 |
| Date Added to Maude | 2016-03-31 |
| 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 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 | SUPERTRAXTRIPLE NEEDLE BRUSH |
| Generic Name | BRONCHIAL BIOPSY BRUSH |
| Product Code | BTG |
| Date Received | 2016-03-31 |
| 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 SUITE 100 MINNEAPOLIS MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-31 |