MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for SENSATION SHORT THROW SINGLE - USE POLYPECTOMY SNARE C E 0086 MOO56265O manufactured by Boston Scientific Corporation.
[144440593]
During a colonoscopy/polyp removal procedure, the snare embedded in polyp, physician unable to remove. The pt required surgical intervention to remove polyp and snare.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086423 |
| MDR Report Key | 8587278 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-04-13 |
| Date Added to Maude | 2019-05-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SENSATION SHORT THROW SINGLE - USE POLYPECTOMY SNARE |
| Generic Name | SNARE, NON - ELECTRICAL |
| Product Code | FGX |
| Date Received | 2019-05-06 |
| Model Number | C E 0086 |
| Catalog Number | MOO56265O |
| Lot Number | 22909514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-06 |