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

Catalog Number RSP0616MFS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

The patient identifier is not known.The patient¿s age is not known.The patient's weight is not known.The lot number of the device is not known.The full udi # information is unavailable since the lot number is unavailable.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 Description

Acclarent was informed on (b)(6) 2017, for an event that occurred on (b)(6) 2017 involving a relieva spinplus kit, 3 guides, 6mm, 5pk (lot# not available).During the primary hybrid balloon sinuplasty procedure, the physician noticed that the blue tip from the balloon catheter had separated from the balloon and was in the sinus cavity.The blue tip was retrieved with forceps.There was no report of any patient consequence and the procedure was not extended.

• Brand Name: RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine 92618 ; 949789-383
• MDR Report Key: 7132458
• MDR Text Key: 95641212
• Report Number: 3005172759-2017-00057
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: K143541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSP0616MFS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1