MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for LUGE H74912130010 manufactured by Boston Scientific Corporation.
[185211133]
Dr placed the luge wire into the copilot and fed it up into the l diag and used a balloon to dilate removed the balloon with no issue. Patient was stented with a 3. 0x24 synergy stent, after flow of the vessel was still slow, luge was removed, and a little resistance was noticed during removal. However, upon removal, the doctor suspected that the tip of the distal wire got stuck on the distal portion of the stent and a small part of the luge wire was left in the vessel. It was the stented again with a 2. 75x20 stent and the small piece was trapped between the wall and the stent so it would not move.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888254 |
| MDR Report Key | 9888254 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-13 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUGE |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DQX |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-02-17 |
| Catalog Number | H74912130010 |
| Lot Number | 247555555 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |