MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-21 for RELIEVA FLEX SINUS GUIDE CATHETER, F-70C GC070CRF manufactured by Acclarent, Inc..
[129307203]
Manufacturer? S ref. No: (b)(4). [conclusion]: acclarent was informed on 10/30/2018, of an event that occurred on (b)(6) 2018, involving the relieva flex sinus guide catheter f-70c (gc070crf / 180405a-pc). During the hybrid functional endoscopic sinus surgery (fess) procedure, the blue tip on the relieva flex sinus guide catheter broke off the guide catheter. It was reported that nothing was left inside the patient? S anatomy; there was no harm or adverse event to the patient. Another guide catheter was opened as a replacement and the procedure was completed. The relieva flex sinus guide catheter f-70c and the separated blue tip were returned for evaluation. The investigation finding is documented below. The lot history record (lhr) was reviewed for lot 180405a-pc. No anomalies were found related to this complaint. In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures. Acclarent received the returned device on 11/19/2018. The package included the following: the relieva flex sinus guide catheter f-70c. The separated blue tip of the guide catheter. Upon receiving the returned device before decontamination, the returned device underwent visual inspected. The relieva flex sinus guide catheter was noted to have a missing blue tip. The separated blue tip included in the package was covered in dry blood. The device underwent decontamination for two hours in a 10% bleach solution. After decontamination, the guide catheter was inspected under the microscope and the reported issue that the blue tip became separated from the guide catheter as reported in the complaint was confirmed. With the information provided in the complaint and the returned device for investigation, the issue reported that the blue tip broke off the guide catheter was confirmed from visual inspection and microscopic inspection of the returned device. Based on the lot history record (lhr) review, there is no indication that the event is related to the device manufacturing process. The exact cause of the failure could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure. Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission. The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report. Additional information will be submitted within 30 days of receipt.
Patient Sequence No: 1, Text Type: N, H10
[129307204]
Acclarent was informed on 10/30/2018, of an event that occurred on (b)(6) 2018, involving the relieva flex sinus guide catheter f-70c (gc070crf / 180405a-pc). During the hybrid functional endoscopic sinus surgery (fess) procedure, the blue tip on the relieva flex sinus guide catheter broke off the guide catheter. It was reported that nothing was left inside the patient? S anatomy; there was no harm or adverse event to the patient. Another guide catheter was opened as a replacement and the procedure was completed. The guide catheter and the separated blue tip will be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2018-00115 |
| MDR Report Key | 8096703 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-21 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2018-11-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA FLEX SINUS GUIDE CATHETER, F-70C |
| Generic Name | CANNULA, SINUS |
| Product Code | LRC |
| Date Received | 2018-11-21 |
| Returned To Mfg | 2018-11-19 |
| Catalog Number | GC070CRF |
| Lot Number | 180405A-PC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-21 |