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

Model Number BC1640A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.The phone and email address of the initial reporter are not available / reported.(b)(4).[conclusion]: the healthcare professional reported that during an airway dilation procedure on the (b)(6)-year-old male patient, the physician was able to dilate the airway using the 14mm x 40mm inspira air balloon dilation system without any issue.Then the physician asked for the 16mm x 40mm inspira air balloon dilation system (bc1640a / 200210-b-pc).Upon inflating, the 16mm x 40mm balloon ruptured along the shaft of the device.The balloon was inflated per the instructions for use (ifu) with 16cc of saline using the acclarent balloon inflation device (bid30 / 96375229) to 8 atm.After fully deflating the device, the balloon came apart in two pieces.The remaining part was removed using a pair of stainless-steel reusable graspers.Additional information provided indicated that there was no issue with the patient¿s anatomy that may have contributed to the reported device issue.It was reported that the bid30 device was also used to inflate the 14mmx 40mm inspira balloon without any issue.The procedure was considered successfully completed as the 16mm x 40mm inspira air balloon provided adequate dilation before it ruptured and nothing additional was required.The patient underwent routine post-op x-ray evaluation to ensure that all fragments of the separated balloon were removed.There was no report of patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (200210-b-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided but without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during an airway dilation procedure on the (b)(6)-year-old male patient, the physician was able to dilate the airway using the 14mm x 40mm inspira air balloon dilation system without any issue.Then the physician asked for the 16mm x 40mm inspira air balloon dilation system (bc1640a / 200210-b-pc).Upon inflating, the 16mm x 40mm balloon ruptured along the shaft of the device.The balloon was inflated per the instructions for use (ifu) with 16cc of saline using the acclarent balloon inflation device (bid30 / 96375229) to 8 atm.After fully deflating the device, the balloon came apart in two pieces.The remaining part was removed using a pair of stainless-steel reusable graspers.Additional information provided indicated that there was no issue with the patient¿s anatomy that may have contributed to the reported device issue.It was reported that the bid30 device was also used to inflate the 14mmx 40mm inspira balloon without any issue.The procedure was considered successfully completed as the 16mm x 40mm inspira air balloon provided adequate dilation before it ruptured and nothing additional was required.The patient underwent routine post-op x-ray evaluation to ensure that all fragments of the separated balloon were removed.There was no report of patient adverse event or complication.

• Brand Name: INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10667102
• MDR Text Key: 211260497
• Report Number: 3005172759-2020-00006
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 10705031147744
• UDI-Public: 10705031147744
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: BC1640A
• Device Catalogue Number: BC1640A
• Device Lot Number: 200210B-PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84