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 2016-02-29 for SUPERDIMENSION TRIPLE NEEDLE CYTOLOGY BRUSH manufactured by Superdimension Inc..
[39303148]
(b)(4). The device was not returned for evaluation. It is unknown which triple needle brush model was used? The lot number is unknown so a dhr review could not 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
[39303149]
The patient experienced bleeding during a superdimension procedure. The site reported that rapid response was implemented and was successful in stopping the bleeding. Per the physician the patient is expected to make a full recovery. The triple needle brush is reported to be the last biopsy tool used prior to the bleeding event. If additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2016-00032 |
| MDR Report Key | 5467812 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-29 |
| Date of Event | 2016-02-02 |
| Date Mfgr Received | 2016-02-02 |
| Date Added to Maude | 2016-02-29 |
| 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 | SUPERDIMENSION TRIPLE NEEDLE CYTOLOGY BRUSH |
| Generic Name | BRONCHIAL BIOPSY BRUSH |
| Product Code | BTG |
| Date Received | 2016-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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; 2. Required No Informationntervention | 2016-02-29 |