MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-22 for SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[113285507]
On 29 june 2018, mw5077936 was received via mail from fda. An mdr (1721279-2018-00063) was submitted 21 may 2018 for this event. However, the report sent from the facility contained additional information: device model and lot numbers now available, including device expiration date and udi. Additional concomitant elca device reported to be used during the procedure. Initial reporter also reported to fda. This information was previously unknown. Device manufacture date now available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721279-2018-00063 |
| MDR Report Key | 7531881 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-22 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-04-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-06-29 |
| Device Manufacturer Date | 2018-01-24 |
| Date Added to Maude | 2018-05-22 |
| 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 | MRS. BARBARA CREEL |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2018-05-22 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018A24A |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-05-22 |