MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-15 for SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[145143490]
Patient's date of birth: unavailable at this time. Device lot number, expiration date: unavailable device manufacture date unavailable because device lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[145143491]
A vascular intervention commenced to treat a lesion in the patient's left anterior descending coronary artery (lad) using a spectranetics elca device, along with a 6f femoral sheath and a run-through wire. Approximately 5 passes were made with the elca device; the first two passes at a fluency of 40/40, then two more at 60/60, before the final pass at 80/80. The laser crossed the lesion without difficulty. However, the angiogram post-laser showed a large perforation at the site of the lesion. Rescue efforts commenced. A balloon tamponade was immediately utilized, followed by two graftmasters which successfully sealed the perforation. The patient survived the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2019-00080 |
| MDR Report Key | 8612871 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-15 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-22 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-15 |
| 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 | MRS. BARBARA CREEL |
| 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 ATHERECTOMY CATHETER |
| Generic Name | ELCA |
| Product Code | LPC |
| Date Received | 2019-05-15 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | UNAVAILABLE |
| 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 | 6 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-05-15 |