MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-08-19 for RELIEVA SINUS BALLOON INFLATION DEVICE BID30 manufactured by Acclarent, Inc..
[1354228]
Event desc: when attempting to use the sinus balloon inflation device, the device would not inflate the balloon. A second device was opened to complete the procedure. Health professional's impression. Unknown. Mfr response for sinus balloon inflation. Device, relieva. Mfr provided rga# for product return eval.
Patient Sequence No: 1, Text Type: D, B5
[8773628]
On (b)(6) 2010, acclarent received a copy of the medwatch form filed by (b)(6) hospital center. The medwatch form was associated with existing complaint: (b)(4). The reported complaint was "failure to inflate". An inflation device associated with this complaint was received on (b)(6) 2010 and was tested with a sample balloon catheter. No abnormal observations were noted. Note, inflation devices and balloon catheters work together as a system. A lot history record review was performed and the lot met all specifications. No trends have been identified with inflation device failures or the inability to inflate balloon catheters. As defined in medical device reporting regulation title 21, part 803, no pt injury, intervention to prevent a serious injury, or malfunction that could lead to a serious injury was reported in this case. Acclarent will continue to update the file with any additional info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2010-00011 |
| MDR Report Key | 1812710 |
| Report Source | 05,07 |
| Date Received | 2010-08-19 |
| Date of Report | 2010-07-02 |
| Date of Event | 2010-06-17 |
| Report Date | 2010-07-01 |
| Date Reported to FDA | 2010-07-01 |
| Date Added to Maude | 2010-08-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK BISHOP, VP |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875843 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA SINUS BALLOON INFLATION DEVICE |
| Generic Name | BALLOON INFLATION DEVICE |
| Product Code | KAM |
| Date Received | 2010-08-19 |
| Returned To Mfg | 2010-07-02 |
| Model Number | BID30 |
| Catalog Number | BID30 |
| Lot Number | 96375024 |
| Device Expiration Date | 2012-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-19 |