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 2020-01-22 for ULTRAFLEX TRACHEOBRONCHIAL M00576530 7653 manufactured by Boston Scientific Corporation.
[176372364]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[176372365]
It was reported to boston scientific corporation on december 30, 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stricture in the left bronchus during an airway stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement. According to the complainant, the stent was positioned in the left bronchus towards the left lower lobe. During deployment, the pull string got "hung up" and the stent was difficult to deploy. The delivery system was adjusted to make the string more fluid to release and deployment was restarted several times with the deployment string getting hung up several times. Towards the end of deployment, the delivery catheter bowed and the stent suddenly deployed in an incorrect location. The stent was removed with forceps and another ultraflex tracheobronchial stent was placed to complete the procedure. There were no patient complications as a result of this event. The patient's condition at the conclusion of the procedure was reported to be good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00072 |
| MDR Report Key | 9616375 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-22 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-09-27 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| Returned To Mfg | 2020-01-20 |
| Model Number | M00576530 |
| Catalog Number | 7653 |
| Lot Number | 0024502752 |
| 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 | 2020-01-22 |