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

Catalog Number BC1640A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot history record review could not be performed as lot number for the acclarent inspira air balloon dilation system was unavailable.Additional information will be submitted within 30 days of receipt.(b)(4).

Event Description

Acclarent was informed on (b)(4) 2018, of an event involving an inspira air balloon dilation system, 16x40mm (lot# unavailable), that was used during an airway dilation procedure that took place in the previous week.The exact date of the procedure is not known.Per the discussion on the phone from the acclarent medical director with the physician who performed the procedure, the procedure was to treat a challenging stenosis extending from the subglottis to the upper trachea on a patient that is reported to be obese and had underwent several airway dilation procedures in the past.Initially in the procedure, the 14mm inspira air balloon was used but the balloon burst; the physician reported that the burst was attributed to the very firm and long nature of the stenosis.The physician reported that balloons have burst treating this patient in the past due to the challenging nature of the stenosis.A 16mm inspira air balloon was used and the balloon was reported to have experience watermelon seeding-like phenomenon which required some proximal pull to control the positioning of the balloon.The balloon suddenly separated from the shaft but was still partially inflated despite being separated from the catheter shaft.The balloon was briefly lodged in the stenosis as a free foreign body.The physician was able to grasp the balloon using a cupped forceps and pulled it forward through the stenosis for a successful retrieval.Upon retrieval, the balloon appeared to have deflated and ruptured.The physician reported that there was some excess force used to pull back on the catheter during the procedure.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
• 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: 7245015
• MDR Text Key: 99787217
• Report Number: 3005172759-2018-00102
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031147744
• UDI-Public: 10705031147744
• Combination Product (y/n): N
• PMA/PMN Number: K110218
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BC1640A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: No
• 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