MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-07-31 for MULTIPLE DEVICES (REF H.10) manufactured by Acclarent, Inc..
[1627405]
This event occurred in one pt. On (b)(6) 2010, customer service was notified of an event which involved bleeding from the anterior ethmoid artery following balloon sinuplasty/spacer implantation on a pt's left frontal sinus. The ent consultant was later notified of 2 post-operative surgical interventions, whereby the pt was taken back to surgery twice to manage the bleeding. At this time, (b)(6) 2010, the complaint was categorized as an mdr. The procedure performed involved a 7x24mm solo pro, following debridement (removal of tissue with a non-acclarent shaver) near the frontal duct. Following the balloon sinuplasty, use of vortex irrigation was used, as well as deployment of a stratus frontal spacer. The ent consultant noted no bleeding following use of acclarent devices. The ent consultant noted that the physician decided to further treat the pt after treating the frontal sinus, but the type of treatment was not disclosed to the ent consultant. Later that day, the pt returned to the hospital with concerns of bleeding. The physician attempted to cauterize the site, and had thought it had been successful. Later that week, the pt returned with further bleeding. At this point, the physician used an external approach involving an incision and clip on the anterior ethmoid artery. This intervention was successful. No further bleeding was noted beyond this point. Follow up with the physician was made twice, and as of (b)(6) 2010, the pt was noted to be fine.
Patient Sequence No: 1, Text Type: D, B5
[8584154]
No specific device was attributed to the bleeding, however, a review of the lot info for luma (lot #091228c), guide catheter (091217a), solo pro (091120a), vortex (091030f-cm), frontal spacer (100106a), as well as historical trending was performed. The lots met specification, and no significant trends were noted. No product malfunction was noted. The devices were not available for return. 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 | 3005172759-2010-00008 |
| MDR Report Key | 1789957 |
| Report Source | 05,07 |
| Date Received | 2010-07-31 |
| Date of Report | 2010-07-27 |
| Date of Event | 2010-02-19 |
| Date Added to Maude | 2010-08-11 |
| 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 | 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 | MULTIPLE DEVICES (REF H.10) |
| Generic Name | MULTIPLE DEVICES (REF H. 10) |
| Product Code | KAM |
| Date Received | 2010-07-31 |
| Model Number | (REF H.10) |
| Catalog Number | (REF H.10) |
| Lot Number | (REF H.10) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-07-31 |