MAUDE Adverse Event Report: ACCLARENT, INC. INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM; BRONCHOSCOPE ACCESSORY

Model Number	BC1640A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient¿s age is not known.The patient¿s gender is not known.The patient's weight is not known.A review of the lot history record the subject device (lot# 160518a-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).
Event or Problem Description
Acclarent was informed on (b)(6) 2017, of an event that occurred on (b)(6) 2017, involving an inspira air balloon dilation system, 16x40mm (lot#: 160518a-pc).It was reported that during the bronchial dilation procedure, the inspira balloon would not deflate.The balloon was replaced and the procedure was completed.There was no report of any patient consequence.

• Brand Name: INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• MDR Report Key: 7132354
• Report Number: 3005172759-2017-00059
• Device Sequence Number: 16593929
• Product Code: LRC
• UDI-Device Identifier: 10705031147744
• UDI-Public: (01)10705031147744(11)160518(17)180518(10)160518A-PC
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K110218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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 Expiration Date: 05/18/2018
• Device Model Number: BC1640A
• Device Catalogue Number: BC1640A
• Device Lot Number: 160518A-PC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1