MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-22 for SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETER 114-009 manufactured by The Spectranetics Corporation.
[139607768]
Patient age and weight could not be obtained from the site. Device has been requested for return but has not yet been received by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[139607769]
A philips representative reported a coronary atherectomy procedure used for a coronary artery disease in the left anterior descending artery(lad). The elca (114-009) device was used for a shockwave in under deployed main stent and the tip of the catheter fragmented off. The tip of the catheter was retrieved and no patient injury occurred. A second elca device was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00052 |
| MDR Report Key | 8445322 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-25 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-04 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2019-03-22 |
| 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 | MISS CATHERINE EATON |
| 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 CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2019-03-22 |
| Model Number | 114-009 |
| Catalog Number | 114-009 |
| Lot Number | FH118M19A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-22 |