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 2018-11-09 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[128427890]
Suspect device has been received by the manufacturer, but evaluation has not yet been performed.
Patient Sequence No: 1, Text Type: N, H10
[128427891]
A philips representative reported that during a coronary atherectomy procedure the physician completed multiple passes with the elca coronary laser atherectomy catheter 110-004. When the device was pulled out of the body it was noticed that a piece of plastic was pointing up next to where the guidewire enters the quick exchange port on the catheter. This may have occurred when removing the elca catheter and did not cause any issues during the procedure. They opened another elca catheter to complete the procedure. No harm to the patient. Procedure completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2018-00157 |
| MDR Report Key | 8055212 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-09 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-10-15 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2018-02-06 |
| Date Added to Maude | 2018-11-09 |
| 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 | MRS. BARBARA CREEL |
| 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 | 2018-11-09 |
| Returned To Mfg | 2018-10-26 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018B06A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-11-09 |