RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK RSP0616MFS

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number3005172759-2018-00105
MDR Report Key7267185
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-02-13
Date of Report2018-01-26
Date of Event2018-01-26
Date Mfgr Received2018-01-26
Device Manufacturer Date2017-07-12
Date Added to Maude2018-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JOAQUIN KURZ
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-383
Manufacturer G1ACCLARENT, INC.
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK
Generic NameINSTRUMENT, ENT MANUAL SURGICAL
Product CodeLRC
Date Received2018-02-13
Returned To Mfg2018-02-06
Catalog NumberRSP0616MFS
Lot Number170712A-PC
Device Expiration Date2019-07-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerACCLARENT, INC.
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-13

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