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 2019-03-04 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 114-009 manufactured by The Spectranetics Corporation.
[137733495]
Patient information is unavailable from the facility. On 28feb2019: 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
[137733496]
A philips representative reported that a coronary atherectomy procedure commenced to treat in-stent re-stenosis (isr) in the protected distal left main artery. Upon withdrawal of the spectranetics coronary laser atherectomy catheter 114-009, the radiopaque ring was seen under fluoroscopic guidance as not coming back with the catheter, indicating detachment. Despite multiple attempts to retrieve the ring, (which was still on the coronary wire at that point), with a snare, and also with a distal embolic protection device, the band was abandoned. It was however, able to be maneuvered into an approximately 1mm diameter sub-branch, secondary to a diagonal branch. The procedure was completed with a final post balloon dilatation. To date the band remains in the patient's vessel without any adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00028 |
| MDR Report Key | 8386401 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-04 |
| Date of Report | 2019-02-08 |
| Date of Event | 2019-02-08 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2017-05-10 |
| Date Added to Maude | 2019-03-04 |
| 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 | 2019-03-04 |
| Returned To Mfg | 2019-02-20 |
| Model Number | 114-009 |
| Catalog Number | 114-009 |
| Lot Number | FTT17E10A |
| 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 | 2019-03-04 |