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 2018-02-13 for RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK RSP0616MFS manufactured by Acclarent, Inc..
[100128774]
Acclarent received the returned maxillary guide catheter (m-110). Visual inspection was performed prior to decontamination and it was observed that the blue tip on the guide catheter was missing. This observation confirmed the issue reported. A review of the lot history record the subject device (lot# 170712a-pc) did not present any issues during the manufacturing or inspection process that can be related to the reported complaint. Additional information will be submitted within 30 days of receipt. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100128775]
Acclarent was informed on (b)(4) 2018, of an event that occurred during the primary balloon sinuplasty procedure on the same day, that involved a relieva spinplus? Balloon sinuplasty system (rsp0616mfs) from lot#: 170712a-pc. The spinplus balloon catheter was being used to treat the maxillary sinus when the tip of the maxillary guide catheter became detached from the shaft and fell into the middle meatus. There was no injury to the nasal or sinus tissue from the tip detachment; the guide catheter tip was retrieved from the sinus cavity using alligator forceps. There was no report of patient injury or complications as a result of the reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2018-00105 |
| MDR Report Key | 7267185 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-26 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-01-26 |
| Device Manufacturer Date | 2017-07-12 |
| Date Added to Maude | 2018-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-383 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE 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 SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2018-02-13 |
| Returned To Mfg | 2018-02-06 |
| Catalog Number | RSP0616MFS |
| Lot Number | 170712A-PC |
| Device Expiration Date | 2019-07-12 |
| 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 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-13 |