MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-18 for FG GATEWAY OTW OUS 2.00MM X 9MM M0032072409200 manufactured by Boston Scientific - Minn.
[124337681]
Itit was reported that when the subject balloon was inflating in the vessel, however,it couldn't be seen because the contrast agent was full of the expanded balloon. The subject balloon was withdrawn from the patient and found plenty of bubble went into the contrast. The operator thought there was invisible leaked point on the subject balloon and made the subject balloon unable to be inflated. The procedure was completed with another one without clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2018-00058 |
| MDR Report Key | 7981170 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-18 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2017-10-31 |
| Date Added to Maude | 2018-10-18 |
| 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 2.00MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2018-10-18 |
| Returned To Mfg | 2018-10-12 |
| Catalog Number | M0032072409200 |
| Lot Number | 21309777 |
| 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 | 2018-10-18 |