MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-14 for FG GATEWAY MR JP 2.00MM X 15MM M0032072115200 manufactured by Boston Scientific - Minn.
[108234871]
The device history record review confirms that the device met all material, assembly and performance specifications. The subject device was returned in two segments. The microcatheter and guidewire used with the balloon catheter were not returned. The balloon was separated at approximately 113. 5cm from its proximal and was severely stretched and separated on its middle shaft. The core wire was protruding through the balloon proximal side separated end. The balloon middle shaft was severely kinked, compressed and wrinkled on several places along its length. The distal shaft was severely kinked, stretched, compressed and wrinkled on several places along its length. The distal shaft was wrinkled in the balloon section as well. The proximal shaft was bent at 3. 0cm and 101. 0cm from its proximal. Functional testing could not be performed due to the damaged condition of the returned catheter. Information available indicated that the device was confirmed to be in good condition prior to use, continuous flush was maintained, patient had a normal anatomy and the guidewire was jammed inside the catheter. Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the balloon catheter contributing to the reported and observed damages. Therefore, an assignable cause of operational context has been assigned to this investigation.
Patient Sequence No: 1, Text Type: N, H10
[108234872]
Analysis of the returned device noted that the balloon catheter was broken. No consequences to the patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2018-00025 |
| MDR Report Key | 7512675 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2015-10-14 |
| Date Added to Maude | 2018-05-14 |
| 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 MR JP 2.00MM X 15MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2018-05-14 |
| Returned To Mfg | 2018-03-08 |
| Catalog Number | M0032072115200 |
| Lot Number | 18510605 |
| Device Expiration Date | 2018-10-31 |
| 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 | 2018-05-14 |