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 2018-10-17 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[124070693]
Patient age and weight were requested, but unavailable from the site. Device lot # was requested, but was unavailable from the site as the device was discarded. The expiration date cannot be determined without a lot#. Device manufactured date cannot be determined without the lot#. The device was discarded by the site. There is no allegation that a malfunction of the device caused or contributed to the reported event.
Patient Sequence No: 1, Text Type: N, H10
[124070694]
A philips representative reported that during a coronary laser atherectomy procedure for a chronic total occlusion of the circumflex artery, the physician was unable to advance through the lesion (balloons, etc. , would not work). The physician began lasing with the elca coronary laser atherectomy catheter 110-004. An artery was perforated. The physician attempted to stop the bleeding with a balloon, but could not. The patient was transferred to the operating room for repair of the injury. Physician was unsure what caused the artery perforation. The patient's status has been requested from the site, but no information has been provided other than what is contained herein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2018-00148 |
| MDR Report Key | 7976271 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-17 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-09-25 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-10-17 |
| 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 | 2018-10-17 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | UNAVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 2018-10-17 |