MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-11-27 for SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETER 110-004 manufactured by Spectranetics.
[92923110]
Patient weight is unavailable. Device lot number and expiration date are unavailable. The device was discarded before this information could be obtained. The device manufacture date is dependent on the device lot number, thus is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[92923111]
It was reported that during a coronary vascular intervention procedure to treat a lesion in the left main artery, a perforation occurred. Reportedly, three passes were made successfully with the elca device. Post-atherectomy angiogram showed a complication in the proximal lad. The lesions were covered with a stent and the patient was stabilized. However, later that night the patient condition worsened and the patient expired. The patient death was reportedly due to multiple co-morbidities coupled with the complication in the lad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2017-00273 |
| MDR Report Key | 7058857 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-02 |
| Date Added to Maude | 2017-11-27 |
| 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 | MR. NICK MCNABB |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-257 |
| Manufacturer G1 | SPECTRANETICS |
| 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 | 2017-11-27 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | UNAVAILABLE |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-11-27 |