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 ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[141079689]
User facility declined to provide the patient's demographic information. Device evaluation completed 28feb2019: attempted to calibrate catheter and received fault code during calibration. Distal tip of catheter was evaluated under microscope and identified 5 dead laser fibers. Proximal coupler fiber pack was evaluated and identified 5 dead fibers. It was observed that the laser beam to the capillary alignment was shifted slightly high. No damage to the tail fuse. Evaluation of the working length identified a broken fiber just distal of the port and a hole in the jacket 5mm distal to the inner lumen exit of the port.
Patient Sequence No: 1, Text Type: N, H10
[141079690]
A philips representative reported that a coronary atherectomy procedure commenced to treat an acute coronary syndrome (acs) event. Patient had severe isr and the laser failed when trying to operate at higher laser energy. Physician used another catheter to complete the case. No patient injury occurred. 28feb2019: during device evaluation, it was detected that there was a breach in the catheter jacket. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00054 |
| MDR Report Key | 8446161 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-14 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2018-10-18 |
| 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 ELCA CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2019-03-22 |
| Returned To Mfg | 2019-02-25 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018K18A |
| 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. Other | 2019-03-22 |