MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-09 for SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER UNAVAILABLE manufactured by The Spectranetics Corporation.
[116702648]
Patient date of birth unavailable. Patient weight unavailable.
Patient Sequence No: 1, Text Type: N, H10
[116702649]
This event was reported at "the (b)(6) annual meeting of the (b)(6) coronary association. " the procedure date is approximate; the actual date of the event is unobtainable. A procedure commenced after the patient experienced sudden chest pain and an emergency coronary angiography revealed a thromboembolic area in the patient's left anterior descending (lad) coronary artery. During the procedure, while a spectranetics elca device was in use, an lad perforation occurred. Rescue efforts began immediately. The area was treated using a balloon for hemostasis. The patient survived the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2018-00105 |
| MDR Report Key | 7770812 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-09 |
| Date of Report | 2018-07-19 |
| Date of Event | 2016-01-01 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-07-19 |
| Date Added to Maude | 2018-08-09 |
| 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 | 2018-08-09 |
| Model Number | UNAVAILABLE |
| 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 | 0 | 1. Required No Informationntervention | 2018-08-09 |