MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-13 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 117-205 manufactured by The Spectranetics Corporation.
[180211326]
Patient date of birth unavailable. Patient age unavailable. Patient weight unavailable.
Patient Sequence No: 1, Text Type: N, H10
[180211327]
A coronary intervention procedure commenced to treat an in-stent restenosis (isr) on the left anterior descending coronary artery (lad), the left circumflex artery (lcx) opening and in the #13 atrioventricular groove of the lcx. Spectranetics ecla os and elca devices were in use during the procedure. While using the elca device, a perforation occurred on lcx #13. They treated the injury using a perfusion catheter and a graftmaster. Patient was transferred to the icu and survived. There was no reported malfunction of the spectranetics device used in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00034 |
| MDR Report Key | 9709065 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-10 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-13 |
| 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 | MS. NICOLE WORFORD |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2020-02-13 |
| Model Number | 117-205 |
| Catalog Number | 117-205 |
| Lot Number | FH318C09A |
| Device Expiration Date | 2020-03-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Product Code | --- |
| Date Received | 2020-02-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-13 |