MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for ELCA CORONARY LASER ATHERECTOMY CATHETER 114-009 manufactured by Spectronetics Corp..
[145482213]
Tip of laser catheter became dislodged. Unable to be retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086690 |
| MDR Report Key | 8616154 |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-01-16 |
| Date Added to Maude | 2019-05-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELCA CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Product Code | LPC |
| Date Received | 2019-05-15 |
| Catalog Number | 114-009 |
| Lot Number | FH118L09A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRONETICS CORP. |
| Manufacturer Address | COLORADO SPRINGS CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-15 |