MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for VALVE IN CARTRIDGE, 9MM PIV-V9 manufactured by Spiration.
[106706148]
Emphysema patient had bronchoscopy for valve removal. The valve was noted to have 3 anchors rather than 5. As reported, the patient coughed up one anchor. The second anchor was not located. The valve was not replaced. Following procedure the patient had significant shortness of breath and cough upon waking up. Patient was prescribed augmentin and steroids for cough. Patient was to be discharged same day (outpatient).
Patient Sequence No: 1, Text Type: N, H10
[106706149]
A patient was doing some chores and had a coughing fit and a piece of metal came out. He took a picture of the piece and sent to physician who believes it is a piece of the valve. He would like to do a chest xray and re-bronch on the patient to ensure that there are no other pieces. Per patient? S wife, he is talking normally and able to move about. He is not in any respiratory distress that has been reported. He did have a respiratory virus last week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2018-00004 |
| MDR Report Key | 7454889 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-02 |
| Date Mfgr Received | 2018-04-02 |
| Date Added to Maude | 2018-04-24 |
| 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 | CYNDY ADAMS |
| Manufacturer Street | 6675 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 425636-545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VALVE IN CARTRIDGE, 9MM |
| Generic Name | SPIRATION VALVE |
| Product Code | OAZ |
| Date Received | 2018-04-24 |
| Model Number | PIV-V9 |
| Lot Number | W00726-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION |
| Manufacturer Address | 6675 185TH AVENUE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-24 |