MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number	RSP0616MFS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient¿s gender is not known.The patient's weight is not known.The lot number of the device is not known.The lot history record review could not be performed as lot number for the acclarent relieva spinplus device was unavailable.If additional information is received regarding this event, a supplemental report will be filed.Manufacturer reference number: (b)(4).
Event or Problem Description
Acclarent was informed on (b)(4) 2017, for an event that occurred on (b)(6) 2017 involving a relieva spinplus kit, 3 guides, 6mm, 5pk (lot# not available).During a primary balloon sinuplasty procedure, while the balloon catheter was being advanced into the left frontal sinus, the blue tapered tip of the balloon catheter separated and fell into the ostiomeatal complex.The separated tip was retrieved by suction.There was no report of any patient consequence.Another device was opened and the procedure was resumed.No non-acclarent devices were used.

• Brand Name: RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• MDR Report Key: 7069500
• Report Number: 3005172759-2017-00053
• Device Sequence Number: 19268716
• Product Code: LRC
• UDI-Device Identifier: 10705031232389
• UDI-Public: 10705031232389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RSP0616MFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR