MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-13 for FG GATEWAY OTW JP 2.00MM X 12MM M0032072012200 manufactured by Boston Scientific - Minn.
[100053796]
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications. Visual examination of the returned device revealed that the catheter was ruptured at 6. 0cm distance to the strain relief, and the inflation shaft tubing had a 0. 5cm rupture. During functional testing, the inflation shaft was leaking due to the ruptured inflation shaft; thus the balloon could not be inflated. Information available indicated that the device was confirmed to be in good condition after unpacking, no anomalies were noted to the device prior to use, the device was prepared as per the dfu, no difficulties were encountered removing the gateway from its packaging. Based on the information available and analysis of the returned device the exact cause for the observed damages to the shaft cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[100053797]
After completing the investigation of the device, it was found that the inflation shaft tubing was ruptured. There were no patient complications reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2018-00008 |
| MDR Report Key | 7268442 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-13 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-11-14 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2016-02-11 |
| Date Added to Maude | 2018-02-13 |
| 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 JP 2.00MM X 12MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2018-02-13 |
| Returned To Mfg | 2017-11-23 |
| Catalog Number | M0032072012200 |
| Lot Number | 18900172 |
| Device Expiration Date | 2019-02-28 |
| Device Availability | R |
| 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 | 2018-02-13 |