MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for SPECTRANETICS LASER manufactured by Spectranetics Corp..
[112707482]
While using the laser the vessel was perforated causing bleeding. Date of use: (b)(6) 2018. Diagnosis or reason for use: cad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078099 |
| MDR Report Key | 7645234 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-04-27 |
| Date Added to Maude | 2018-06-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPECTRANETICS LASER |
| Generic Name | DEVICE, ANGIOPLASTY LASER |
| Product Code | LPC |
| Date Received | 2018-06-27 |
| Lot Number | FG018A24A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-06-27 |