MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-19 for SPECTRANETICS LASER ELCA CATHETER 110-004 manufactured by Spectranetics / Philips.
[111845151]
While using the laser, the vessel was perforated causing bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077936 |
| MDR Report Key | 7619006 |
| Date Received | 2018-06-19 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-04-27 |
| Date Added to Maude | 2018-06-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | SPECTRANETICS LASER ELCA CATHETER |
| Generic Name | ANGIOPLASTY LASER |
| Product Code | LPC |
| Date Received | 2018-06-19 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018A24A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS / PHILIPS |
| Manufacturer Address | COLORADO SPRINGS CO US |
| Brand Name | SPECTRANETICS LASER ELCA CATHETER |
| Generic Name | ANGIOPLASTY LASER |
| Product Code | LPC |
| Date Received | 2018-06-19 |
| Model Number | 110-004 |
| Catalog Number | 110-004 |
| Lot Number | FG018A24A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS PHILIPS |
| Manufacturer Address | COLORADO SPRINGS CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-06-19 |