MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2010-06-16 for IBV VALVE SYSTEM REF-HU-VS-7 manufactured by Spiration Inc..
[1404440]
The following was reported by the doctor and nurse who treated the patient: the valve was placed for patient (b)(6) on (b)(6) 2009 and the air leak ceased on (b)(6) 2009. The patient was discharged to his home on (b)(6) 2009. Since his discharge, he has had recurrent respiratory infections. The patient returned on (b)(6) 2010 to have bronchoscopy and removal of the valve. The bronchoscopy revealed granulation tissue at the site making it difficult to see the valve. After several attempts, the doctor was able to get past the granulation tissue and grab the valve with a rat tooth grasper and remove it. There was no sign of any infectious process at the valve site. The valve was retrieved and the patient tolerated the procedure well. This event was considered definitely related due to the development of the granulation tissue at the valve site and possibly related for the infection. Subsequent to the valve removal, the recurrent infections have ceased. This risk is expected as it is listed in the patient brochure.
Patient Sequence No: 1, Text Type: D, B5
[8621151]
Spiration reviewed device labeling and device manufacturing record. There were no unusual occurrences observed during the manufacturing of the valve. No deviations or acceptance of non-conforming material occurred. Spiration requested additional information from the reporting institution regarding whether the adverse event was related or not to device and whether it was anticipated or unanticipated. This report is being submitted as an mdr with an abundance of caution. If additional significant information is provided, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004450998-2010-00002 |
| MDR Report Key | 1728835 |
| Report Source | 04,05,06 |
| Date Received | 2010-06-16 |
| Date of Report | 2010-06-16 |
| Date of Event | 2010-03-16 |
| Date Mfgr Received | 2010-05-18 |
| Device Manufacturer Date | 2009-11-13 |
| Date Added to Maude | 2011-05-27 |
| 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 | LINDA SHEETZ RISMONDO |
| Manufacturer Street | 6675 - 185TH AVENUE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254971700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IBV VALVE SYSTEM |
| Generic Name | ONE-WAY AIR LEAK VALVE |
| Product Code | OAZ |
| Date Received | 2010-06-16 |
| Catalog Number | REF-HU-VS-7 |
| Lot Number | W03749-01 |
| Device Expiration Date | 2011-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-16 |