MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for ELCA? 110-004 manufactured by Spectranetics Corporation.
[134331504]
Patient had a cardiac catheterization performed about 3 months ago. Cardiac catheterization showed total occlusion of the left anterior descending artery, therefore, the patient was scheduled for percutaneous coronary intervention (pci) about one week later. During angioplasty, chronic total occlusion was successfully crossed with the wire. Due to calcification, laser atherectomy was used. After atherectomy the patient complained of chest pain and had a drop in blood pressure. Coronary angiogram showed a perforation in the mid left anterior descending artery and pericardial tamponade requiring surgery to repair. Patient had an impella device placed for life support. Patient developed abdominal compartment syndrome and was in shock. The family made her comfort care and she passed away two days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8284663 |
| MDR Report Key | 8284663 |
| Date Received | 2019-01-29 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-11-07 |
| Report Date | 2018-12-28 |
| Date Reported to FDA | 2018-12-28 |
| Date Reported to Mfgr | 2019-01-29 |
| Date Added to Maude | 2019-01-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELCA? |
| Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
| Product Code | LPC |
| Date Received | 2019-01-29 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018G02A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-01-29 |