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 2020-02-24 for ULTRAFLEX TRACHEOBRONCHIAL M00576570 7657 manufactured by Boston Scientific Corporation.
[188654704]
(b)(4). The device has been received for analysis; however the analysis has not yet been completed. Upon 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
[188654705]
It was reported to boston scientific corporation that a ultraflex tracheobronchial stent 14x30 was to be used to treat a malignancy in the left main stem of the trachea during a stent implantation procedure on (b)(6) 2020. According to the complainant, during the procedure and after the stent was deployed, the physician noticed that one of the struts was broken and the wire was poking out. Reportedly, for the patient's safety, the physician decided to remove the stent with rat tooth forceps. As the stent was being removed, the stent got stuck in the laryngeal mask airway. The stent was replaced with another ultraflex tracheobronchial stent 14x30 stent from the shelf. 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 fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00513 |
| MDR Report Key | 9747227 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-05-21 |
| Date Added to Maude | 2020-02-24 |
| 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 | 2020-02-24 |
| Model Number | M00576570 |
| Catalog Number | 7657 |
| Lot Number | 0023825280 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-24 |