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 2018-10-15 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[125648330]
Visual and microscopic evaluation of the suspect device found that the jacket of the catheter was lifted at the guidewire lumen fuse-point, 9mm from distal tip. Inner lumen was also lifted (did not lay flush with rest of device). No laser fibers were exposed. Failure occurred at fuse joint. Unable to pass guidewire through device during testing as guidewire entry point and inner-lumen were deformed. Philips field representative reported that the cardiologist was having difficulty with his guide support. He lost placement the guide which pulled the guide wire and fiber catheter back simultaneously. He said that the catheter may have gotten caught on a stent strut.
Patient Sequence No: 1, Text Type: N, H10
[125648331]
A philips representative reported that during a coronary laser atherectomy procedure for in-stent re-stenosis, the spectranetics coronary atherectomy catheter (elca) 110-004 device was used. When taken out of the patient, it was discovered there was a deformation in the outer jacket of the device where the guidewire enters the inter-lumen of the catheter. The physician used another disposable elca catheter and the case was completed successfully. No impact/harm to the patient occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2018-00145 |
| MDR Report Key | 7967056 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-15 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-09-17 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2018-10-15 |
| 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 | 2018-10-15 |
| Returned To Mfg | 2018-10-08 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018E31A |
| 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 | 2018-10-15 |