MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-03 for RELIEVA FLEX SINUS GUIDE CATHETER GC110RF manufactured by Acclarent.
[21530135]
Acclarent was notified on (b)(6) 2014 of an international event that occurred on (b)(6) 2014 during a sinus surgical case when acclarent balloon dilation technology was used. The physician tried to access the right maxillary sinus and there was a tight space with tissue edema that made it very difficult to position the guide catheter tip. He managed to rotate from tip down position at the uncinated process. Then, he moved to left maxillary sinus and there was a tight space also and he managed to rotate the guide catheter tip at the uncinate. The physician went back to the right maxillary sinus and when he managed to turn the guide catheter tip behind the uncinate process, the distal tip was tore off. The physician used rigid instruments to remove the distal tip from behind the pt's uncinate process. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[21664452]
Complaint devices arrived on 02/11/2014 and failure analysis was performed on 02/12/2014. The returned package included a flex guide catheter m-110 and a 5x16mm balloon catheter. The following observations were note during eval: the flex m-110-guide catheter's blue tip was detached from the guide catheter. The blue tip was inside the returned bag. Upon inspection under the microscope, delamination damages were found inside the tip. There were scratches and pinches around distal of linear and blue tip area. The flex guide catheter was checked and there was material known as the nylon material between linear and nylon section which was peeling off from the pebax. The balloon catheter hypo tube was kinked near the white maker band. The catheter was tested by connected it to the sample inflation device, filled with water under pressure, the balloon was inflated to 12atm w/o losing pressure. The balloon did not leak during inflation and deflation. 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 | 3005172759-2014-00002 |
| MDR Report Key | 3745478 |
| Report Source | 05 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-02-05 |
| Date of Event | 2014-02-05 |
| Date Mfgr Received | 2014-02-05 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-05-07 |
| 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 BARRETT |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA FLEX SINUS GUIDE CATHETER |
| Generic Name | FLEX GUIDE CATHETER |
| Product Code | KAM |
| Date Received | 2014-03-03 |
| Returned To Mfg | 2014-02-11 |
| Model Number | NA |
| Catalog Number | GC110RF |
| Lot Number | 130730E-CM |
| ID Number | NA |
| Device Expiration Date | 2015-07-30 |
| 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 |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-03 |