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 2020-01-28 for ULTRAFLEX ESOPHAGEAL NG M00513800 1380 manufactured by Boston Scientific Corporation.
[188208217]
Initial reporter title: team leader endoscopy unit. (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
[188208218]
It was reported to boston scientific corporation on january 06, 2020 that an ultraflex esophageal ng proximal release uncovered stent was implanted in the oesophagus during a stent placement procedure performed on (b)(6) 2019. According to the complainant, on (b)(6) 2019, it was felt that the stent did not stay fully open. The patient was re-scoped and it was confirmed that the stent failed to expand and was not fully open. The physician tried to expand the stent using a dilatation balloon catheter and then it opened with the use of rat tooth forceps. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00132 |
| MDR Report Key | 9639729 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-03-06 |
| Date Added to Maude | 2020-01-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 ESOPHAGEAL NG |
| Generic Name | PROSTHESIS, ESOPHAGEAL |
| Product Code | ESW |
| Date Received | 2020-01-28 |
| Model Number | M00513800 |
| Catalog Number | 1380 |
| Lot Number | 0023444782 |
| 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 | 2020-01-28 |