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 2018-08-29 for RELIEVA FLEX SINUS GUIDE CATHETER, M-110 GC110RF manufactured by Acclarent, Inc..
[118899708]
(b)(4). Information regarding patient identifier, weight, race, ethnicity, and medical history were not provided. [conclusion]: the healthcare professional reported that during the attempt to irrigate the maxillary sinus during the primary procedure on (b)(6) 2018, the blue tips at the end of the relieva flex sinus guide catheter, m-110 (gc110rf) came off on both catheters from the same lot (170112a-pc). Additional follow-up was performed on (b)(6) 2018, and the sales representative stated that the tip was still connected to the guide catheter. It was replaced, and the same issue occurred with the second catheter. The two guide catheters were returned for evaluation. One of the guide catheters was found to be missing the blue tip. The sales representative was contacted again for clarification, and she reported that when the guide catheter was removed from the patient the tip was still partially attached to the device; the blue tip fell off during the inspection of the guide catheter outside of the patient? S anatomy. A third guide catheter was used to successfully complete the procedure. There was no report of any patient injury or adverse event. The relieva flex sinus guide catheter, m-110 was returned and received on 08/01/2018. The device was visually inspected prior to undergoing decontamination. The blue tip at the end of the guide catheter was observed to be missing. The reported issue was verified. The lot history record (lhr) was reviewed for lot the 170112a-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. With the information in the complaint and the additional information provided, the condition of the returned device was confirmed. Based on the device history record review, there is no indication that the event is related to the device manufacturing process. The cause of the initial partial tip separation could not be conclusively determined; the tip became completely separated when the removed device was being inspected. It is possible that the circumstance of the procedure and/or the device manipulation during the procedure may have contributed to the reported issue. 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
[118899709]
The healthcare professional reported that during the attempt to irrigate the maxillary sinus during the primary procedure on (b)(6) 2018, the blue tips at the end of the relieva flex sinus guide catheter, m-110 (gc110rf) came off on both catheters from the same lot (170112a-pc). Additional follow-up was performed on (b)(6) 2018, and the sales representative stated that the tip was still connected to the guide catheter. It was replaced, and the same issue occurred with the second catheter. The two guide catheters were returned for evaluation. One of the guide catheters was found to be missing the blue tip. The sales representative was contacted again for clarification, and she reported that when the guide catheter was removed from the patient the tip was still partially attached to the device; the blue tip fell off during the inspection of the guide catheter outside of the patient? S anatomy. A third guide catheter was used to successfully complete the procedure. There was no report of any patient injury or adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2018-00113 |
| MDR Report Key | 7829635 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2018-08-29 |
| 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, M-110 |
| Generic Name | CANNULA, SINUS |
| Product Code | LRC |
| Date Received | 2018-08-29 |
| Returned To Mfg | 2018-08-01 |
| Catalog Number | GC110RF |
| Device Expiration Date | 2019-01-12 |
| 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 | 2018-08-29 |