MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-26 for ULTRAFLEX TRACHEOBRONCHIAL M00564870 6487 manufactured by Boston Scientific Corporation.
[172902288]
(b)(6). (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[172902289]
It was reported to boston scientific corporation on december 09, 2019 that an ultraflex tracheobronchial stent was to be used to treat a stricture in the main airway carina during tracheal stent implantation performed on (b)(6) 2019. Reportedly, the patient's anatomy was dilated prior to stent placement. According to the complainant, after the stent deployed, the physician checked the stent using the bronchoscope and noted that the stent was slow to fully expand. Five minutes post stent implantation, the patient sat up and experienced dyspnea leading to heart failure. The physician then decided to remove the stent and the procedure was completed with another ultraflex tracheobronchial stent. The patient's condition at the conclusion of the procedure was reported to be stable but the physician also noted that the patient had pneumothorax. In the physician's assessment, the heart failure, dyspnea and pneumothorax were related to the stent. Reportedly, according to the physician the heart failure and dyspnea were caused by the stent failing to fully expand in the trachea. According to the physician, the pneumothorax was caused by the heart failure. The endoscopic stent removal was the only intervention reported to address the heart failure, dyspnea and pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06295 |
| MDR Report Key | 9520044 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-26 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-01-24 |
| Date Added to Maude | 2019-12-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAFLEX TRACHEOBRONCHIAL |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
| Product Code | JCT |
| Date Received | 2019-12-26 |
| Returned To Mfg | 2020-01-09 |
| Model Number | M00564870 |
| Catalog Number | 6487 |
| Lot Number | 0023237942 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-26 |