MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-25 for RELIEVA SOLO BALLOON CATHETER GCO20RS * manufactured by Acclarent, Inc..
[19249813]
The sinus guide catheter was introduced into the sinus under endoscopic visualization. A flexible sinus guidewire was introduced through the sinus guide catheter and advanced within the target sinus under fluoroscopic guidance. The position of the sinus balloon catheter was confirmed, and was gradually dilated, when the balloon broke off the end of the guide while in the sinus. The physician was able to remove the entire balloon and guide without any problems. The guide and balloon were given to the surgical service team leader to return to the company for an evaluation. There was no adverse outcome to the patient related to the rupture of the balloon.
Patient Sequence No: 1, Text Type: D, B5
[19283969]
The sinus guide catheter was introduced into the sinus under endoscopic visualization. A flexible sinus guidewire was introduced through the sinus guide catheter and advanced within the target sinus under fluoroscopic guidance. The position of the sinus balloon catheter was confirmed, and was gradually dilated, when the balloon broke off the end of the guide while in the sinus. The physician was able to remove the entire balloon and guide without any problems. The guide and balloon were given to the surgical service team leader to return to the company for an evaluation. There was no adverse outcome to the patient related to the rupture of the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1362661 |
| MDR Report Key | 1362661 |
| Date Received | 2009-03-25 |
| Date of Report | 2009-03-24 |
| Date of Event | 2009-03-05 |
| Report Date | 2009-03-24 |
| Date Reported to FDA | 2009-03-25 |
| Date Added to Maude | 2009-04-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA SOLO BALLOON CATHETER |
| Generic Name | BALLOON CATHETER, SINUS |
| Product Code | KAO |
| Date Received | 2009-03-25 |
| Model Number | GCO20RS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 1525-B O'BRIEN PARK DRIVE MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-25 |