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 2019-12-17 for ULTRAFLEX TRACHEOBRONCHIAL M00564770 6477 manufactured by Boston Scientific Corporation.
[175235192]
Initial reporter's address 1: (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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[175235193]
It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a broncho-pleural fistula in the right main bronchus during a tracheal stent implantation procedure performed on (b)(6) 2019. Reportedly, patient's anatomy was dilated prior to stent placement. According to the complainant, during the procedure, the stent was able to be deployed. However, it was noticed that the stent failed to expand. The physician used a balloon catheter to dilate the stent but the stent could not be fully expanded, and the stent sipped towards the distal end of the bronchus. The stent was removed with forceps and another ultraflex tracheobronchial stent was placed to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-05986 |
| MDR Report Key | 9482618 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-17 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-11-26 |
| Device Manufacturer Date | 2018-03-06 |
| Date Added to Maude | 2019-12-17 |
| 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 | 2019-12-17 |
| Model Number | M00564770 |
| Catalog Number | 6477 |
| Lot Number | 0021825075 |
| Device Expiration Date | 2020-03-05 |
| 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 | 2019-12-17 |