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 2019-02-13 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 114-009 manufactured by The Spectranetics Corporation.
[136036914]
Patient age and weight unavailable from the site. Visual and microscopic evaluation of the suspect elca device found that the band was cleanly separated from the tip of the catheter. There were no broken or bent laser fibers on the distal tip of the device. There were no splits or cracks on the band. Cause of event cannot be determined with the information available.
Patient Sequence No: 1, Text Type: N, H10
[136036915]
A philips representative reported that during a coronary procedure for an in-stent re-stenosis vein graft, a spectranetics coronary laser atherectomy catheter 114-009 was being utilized in the patient's anatomy when the radio-opaque marker band came off the tip of the catheter. The physician was able to remove the tip from the patient successfully. No adverse affect on the patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00018 |
| MDR Report Key | 8336043 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-18 |
| Date of Event | 2019-01-18 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2019-02-13 |
| 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 | 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 ELCA CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2019-02-13 |
| Returned To Mfg | 2019-01-25 |
| Model Number | 114-009 |
| Catalog Number | 114-009 |
| Lot Number | FH118L29A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-13 |