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 2019-03-08 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[142351545]
Patient information was unavailable from the user facility. On 17jan2019: visual and microscopic evaluation of the suspect elca device found that the inner lumen of the device was occluded with tissue. The tissue was cleared out by pushing a guide wire through the device bifurcate. Distal tip of catheter evaluated: laser fibers were chipped at the distal tip of the device and four non-functional fibers present. Excessive degradation was observed at the tip, evidenced by heavy erosion and damage to the outer jacket near the tip. Proximal coupler was evaluated: the proximal end of the catheter where it plugs into the laser system, looked good with a few cracked laser fibers. Additional evaluation completed 14feb2019. During this evaluation a small hole was detected in the working length of the catheter's outer jacket while manipulating the jacket with tweezers under microscope.
Patient Sequence No: 1, Text Type: N, H10
[142351546]
A philips representative reported that during a peripheral laser atherectomy procedure the spectranetics coronary laser atherectomy catheter (elca) would not lase as expected. A second elca catheter was used to complete the case with no reported patient harm. The device was returned and evaluated. During evaluation it was detected that the device outer jacket was damaged in such a way that an accidental laser radiation occurrence is possible. 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 | 1721279-2019-00034 |
| MDR Report Key | 8406045 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-08 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-12-21 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2018-03-22 |
| Date Added to Maude | 2019-03-08 |
| 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 | 2019-03-08 |
| Returned To Mfg | 2019-01-15 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018C22A |
| 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 | 2019-03-08 |