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

Catalog Number	BC1640A
Medical Device Problem Codes	Detachment Of Device Component (1104); Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient identifier is not known.The patient¿s age / date of birth is not known.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 inspira air balloon dilation system was unavailable.If additional information is received regarding this event, a supplemental report will be filed.(b)(4).
Event or Problem Description
Acclarent was informed on 01/11/2018, of an event involving an inspira air balloon dilation system, 16 x 40 mm (lot# unavailable), that was used during an airway dilation procedure that took place approximately 3 to 4 months before that was thought to have been reported to acclarent.Per the discussion on the phone from the acclarent medical director with the physician who performed the procedure, the procedure was to treat a subglottic stenosis using a 14 or 16 mm inspira air balloon.The physician was not able to recall the exact size of the balloon and the balloon has since been discarded.The event reported was the inspira air balloon appeared to have partially separated from the shaft of the catheter and there was difficulty in deflating the balloon.The balloon deflation was achieved by being punctured in the airway using a long-handled knife.The balloon was carefully retrieved from the airway.The patient was reported to have achieved some dilation and did not require any additional surgical intervention.The patient did not suffer any adverse event associated with the reported event.

• 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: 7241443
• Report Number: 3005172759-2018-00103
• Device Sequence Number: 1223337
• Product Code: LRC
• UDI-Device Identifier: 10705031147744
• UDI-Public: 10705031147744
• Combination Product (Y/N): N
• PMA/510(K) Number: K110218
• 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): 01/11/2018

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: BC1640A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1