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 2020-02-03 for WALLFLEX ESOPHAGEAL manufactured by Boston Scientific Corporation.
[178146430]
The complainant was unable to provide the suspect device upn and lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). According to the complainant, the suspect device was discarded and will not available for return; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified , a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178146431]
It was reported to boston scientific corporation on january 10, 2020 that a wallflex esophageal fully covered stent was implanted to treat a malignant stenosis in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2020. According to the complainant, during recovery, the stent started to come out while suctioning the patient. The patient coughed up the stent which was later removed. The procedure was completed with another wallflex esophageal stent. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00242 |
| MDR Report Key | 9660998 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-03 |
| 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 | WALLFLEX ESOPHAGEAL |
| Generic Name | PROSTHESIS, ESOPHAGEAL |
| Product Code | ESW |
| Date Received | 2020-02-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-03 |