MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-03 for SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[144087748]
Weight not available from facility.
Patient Sequence No: 1, Text Type: N, H10
[144087749]
A vascular intervention case commenced to treat left anterior descending artery (lad) stenosis. The physician began the procedure using a spectranetics elca device (110-004). Midway through the procedure, the patient complained of a chest pain. The physician used an angiogram to take a picture of the vessel. A perforation was noticed in the mid/distal area of the lad. The physician stented the entire lad. The physician then used an echo-cardiogram and noticed some cardiac diffusion which he viewed as not critical at the time. The physician administered protamine. Patient pressure remained fine and heart rate was fine. Decision was made to take her off the table and admit her and observe overnight. In holding the patient was unresponsive. The patient was put on extracorporeal membrane oxygenation (ecmo), which still did not stabilize the patient. Patient passed away around 11pm on (b)(6) 2019. Later, the philips representative confirmed with the physician, the elca device was in the location of the perforation of the lad. The representative and physician also confirmed no malfunction of the elca device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00067 |
| MDR Report Key | 8580167 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-04-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2019-03-12 |
| Date Added to Maude | 2019-05-03 |
| 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 | MS. JESSICA DOMINGUEZ |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-258 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2019-05-03 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG019C12A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2019-05-03 |