MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-02 for FG GATEWAY OTW OUS 1.50MM X 9MM M0032072409150 manufactured by Boston Scientific - Minn.
[126386807]
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications. Analysis of the returned device found that the catheter was kinked and noted the balloon was punctured. During functional testing, a demo guidewire was introduced to the catheter with slight resistance upon advancement. Additionally, the balloon leaked during inflation attempts. Due to the leak from the punctured balloon, the balloon could not be inflated; the reported event was confirmed. Additional information provided by the customer confirmed the device was prepared per directions for use (dfu) and in good condition after unpacking and preparation. It was further reported there was high stenosis proximal to the lesion and the lesion was heavily calcified. Based on the information provided and analysis of the returned device, it is likely that the gateway was damaged while being advanced into the patient due to the high stenosis and calcification at the lesion site. The damage to the device (kinked shaft and punctured balloon), which subsequently affected the functional performance (difficulty loading guidewire, failure to inflate, and leakage) is likely due to procedure factors encountered during procedure. As such, cause traced to component failure was assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[126386808]
Analysis of the returned device found the balloon had a hole and was leaking. There was no clinical consequence to the patient as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2018-00060 |
| MDR Report Key | 8035357 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2018-11-02 |
| 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 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2018-11-02 |
| Returned To Mfg | 2018-09-12 |
| Catalog Number | M0032072409150 |
| Lot Number | 20218303 |
| 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 | 2018-11-02 |