MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-06 for RELIEVA FLEX SINUS GUIDE CATHETER GC090RF manufactured by Acclarent, Inc..
[4650354]
Acclarent was notified on (b)(4) 2014, of an domestic event that occurred on (b)(6) 2014 during a sinus surgical case when acclarent balloon dilation technology was used. The first two attempts to access the maxillary sinus with the guide catheter were successful with no issue. On the third attempt to access maxillary sinus, the blue tip of m-90 flex guide catheter fell off. There was no pt injury and the blue tip was retrieved.
Patient Sequence No: 1, Text Type: D, B5
[11927724]
Complaint device arrived on (b)(4) 2014 and failure analysis was performed on (b)(6) 2014. The returned package included: one flex guide catheter m-90. The blue tip was detached from the guide catheter and it was inside the plastic bag. Upon inspection under the microscope, delaminating damages were found inside the tip. There were scratches and pinches around distal of linear and blue tip area. There was material known as the nylon material between linear and nylon section which was peeling off from the pebax. Based on the investigation results, it is suspected that the damage could be the result of user used excessive force to manipulate the guide catheter. Acclarent will continue to monitor this phenomenon for trending purposes. This report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00005 |
| MDR Report Key | 3907056 |
| Report Source | 05 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-02-14 |
| Date of Event | 2014-02-14 |
| Date Mfgr Received | 2014-02-14 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-07-15 |
| 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 | MONICA BARRET |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506874948 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA FLEX SINUS GUIDE CATHETER |
| Generic Name | FLEX GUID CATHETER |
| Product Code | KAM |
| Date Received | 2014-03-06 |
| Returned To Mfg | 2014-02-21 |
| Model Number | NA |
| Catalog Number | GC090RF |
| Lot Number | 130626F-CM |
| ID Number | NA |
| Device Expiration Date | 2015-06-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 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 | 2014-03-06 |