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

Model Number BC1640A

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

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 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
• Type of Device: BRONCHOSCOPE ACCESSORY
• 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: 7132354
• MDR Text Key: 95641441
• Report Number: 3005172759-2017-00059
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031147744
• UDI-Public: (01)10705031147744(11)160518(17)180518(10)160518A-PC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

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 Expiration Date: 05/18/2018
• Device Model Number: BC1640A
• Device Catalogue Number: BC1640A
• Device Lot Number: 160518A-PC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2017
• Date Device Manufactured: 05/18/2016
• 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