MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for ENDOVIVE SAFETY PEG KIT - RETRIEVAL SNARE M00566090 manufactured by Boston Scientific Corporation.
[183291078]
Upon attempted activation of the retrieval snare in the endovive safety peg kit, there was a snapping sound and the snare would not open. Plastic covering by the catheter / wire junction was discovered to be broken. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093652 |
| MDR Report Key | 9817929 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-06 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3 |
| Brand Name | ENDOVIVE SAFETY PEG KIT - RETRIEVAL SNARE |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2020-03-10 |
| Model Number | M00566090 |
| Lot Number | 24994563 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |