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 2018-11-30 for SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by The Spectranetics Corporation.
[128917349]
Although requested the device has not been returned for evaluation at this time. There is no allegation of a malfunction of the elca device.
Patient Sequence No: 1, Text Type: N, H10
[128917350]
A philips representative reported that during a coronary vascular intervention procedure to treat a severely calcified lesion in the mid segment of the left anterior descending (lad) artery, a spectranetics elca coronary laser atherectomy catheter 110-004 device was used, and the diagonal of the lad vessel was perforated. The physician placed a cover stent and the patient was transported to the operating room for surgery. The patient survived the procedure. There is no allegation of a malfunction of the elca device.
Patient Sequence No: 1, Text Type: D, B5
[140178709]
During a review of fda website on (b)(6) 2019, it was discovered that a medsun entry was present for this complaint event. On (b)(6) 2019, manufacturer received hard copy of the medsun report pertaining to this complaint event (report # (b)(4)); both reported that patient died two days after the procedure. This follow up mdr is being submitted to, capture the fact that the patient died.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721279-2018-00165 |
| MDR Report Key | 8120621 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-11-07 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-02-04 |
| Device Manufacturer Date | 2018-07-02 |
| Date Added to Maude | 2018-11-30 |
| 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 | 2018-11-30 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018G02A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-11-30 |