MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-19 for FG GATEWAY OTW OUS 2.50MM X 15MM M0032072415250 manufactured by Boston Scientific - Minn.
[127855402]
Subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[127855403]
It was reported that during preparation, it was not possible to purge the air and inflate the balloon and balloon rupture/leak of saline solution was observed. There were no clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2018-00064 |
| MDR Report Key | 8087434 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-19 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2018-12-24 |
| Device Manufacturer Date | 2017-11-14 |
| Date Added to Maude | 2018-11-19 |
| 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 | MR. TARA LOPEZ |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MINN |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FG GATEWAY OTW OUS 2.50MM X 15MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2018-11-19 |
| Returned To Mfg | 2018-11-14 |
| Catalog Number | M0032072415250 |
| Lot Number | 21364859 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MINN |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |