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 2020-01-16 for ULTRAFLEX TRACHEOBRONCHIAL M00564830 6483 manufactured by Boston Scientific Corporation.
[177579860]
(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
[177579861]
It was reported to boston scientific corporation on december 27, 2019 that an ultraflex tracheobronchial covered distal release stent was implanted to treat a malignant stenosis in the weasand during a stenting procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was not dilated prior to stent placement. According to the complainant, 1 to 2 hours after stenting procedure, the patient experienced discomfort and was coughing severely. It was later confirmed under the scope that the stent migrated. The physician attempted to place the stent back to the stenosis by pulling on the suture using forceps; however, it failed. The stent was removed with forceps and another stent was implanted to complete the procedure. The patient's condition at the conclusion of the procedure was reported to be stable and no additional intervention was done to address the patient's cough and discomfort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00066 |
| MDR Report Key | 9598482 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-07-31 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2017-08-02 |
| Date Added to Maude | 2020-01-16 |
| 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 | 2020-01-16 |
| Model Number | M00564830 |
| Catalog Number | 6483 |
| Lot Number | 0020960120 |
| Device Expiration Date | 2019-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-16 |