MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-12 for FG GATEWAY OTW OUS 1.50MM X 15MM M0032072415150 manufactured by Boston Scientific - Minn.
[116860192]
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications. During the analysis of the returned device found that the shaft of the inflation port appeared to be perforated. Attempts made to inflate the device to nominal pressure were unsuccessful. The balloon would not inflate normally and water was leaking through the guidewire port from the hole in the inflation port. Further analysis of the returned device revealed perforations in the proximal inner shaft directly under the hub inflation port. Based on the size and location of the perforations, it is possible the guidewire was mistakenly inserted into the hub inflation port instead of the guidewire (back) port which punctured the inner shaft and caused the observed leakage/failure to inflate during device analysis. Per the device direction for use (dfu), "introduce the guidewire, flexible-end first, into the straight (back) port. " however, since the guidewire used in the procedure was not returned, this could not be proven. While there are a number of potential causes for the reported issue, because review of available information and analysis of the returned device failed to identify a definitive cause,therefore, an assignable cause of undeterminable was assigned.
Patient Sequence No: 1, Text Type: N, H10
[116860193]
Analysis of the returned device found that that the subject device catheter shaft was broken and water was leaking from the guidewire port. There was no clinical consequence to the patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2018-00039 |
| MDR Report Key | 7775635 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-12 |
| Date of Report | 2018-08-12 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-07-17 |
| Device Manufacturer Date | 2016-09-22 |
| Date Added to Maude | 2018-08-12 |
| 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 1.50MM X 15MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2018-08-12 |
| Returned To Mfg | 2018-06-15 |
| Catalog Number | M0032072415150 |
| Lot Number | 19740992 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-12 |