MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-03 for INSPIRA AIR BALLOON DILATION SYSTEM, 14X40MM BC1440A manufactured by Acclarent, Inc..
[132089619]
(b)(4). The lot history record (lhr) was reviewed for lot 180817b-pc. No anomalies were found related to this complaint. In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures. 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.
Patient Sequence No: 1, Text Type: N, H10
[132089620]
Acclarent was informed on (b)(6) 2018, of an event that occurred during the airway dilation procedure on (b)(6) 2018, involving the 14 x 40mm inspira air balloon dilation system (bc1440a / 180817b-pc). It was reported that upon the second dilation, the inspira air balloon could not become fully deflated; this issue was reported to have occurred outside of the patient? S airway. It was reported that the guide/balloon was not flushed prior to use. The inspira balloon was replaced with another 14 x 40mm inspira air balloon and the procedure was continued and successfully completed with the replacement device. There was no report of any patient consequence or adverse event associated with the issue. The inspira air balloon was reported to have been discarded and is not available to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2019-00116 |
| MDR Report Key | 8214946 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-03 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2018-08-17 |
| Date Added to Maude | 2019-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSPIRA AIR BALLOON DILATION SYSTEM, 14X40MM |
| Generic Name | BRONCHOSCOPE ACCESSORY |
| Product Code | LRC |
| Date Received | 2019-01-03 |
| Catalog Number | BC1440A |
| Lot Number | 180817B-PC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-03 |