Brand Name | SPECTRANETICS LEAD LOCKING DEVICE |
Type of Device | LLD |
Manufacturer (Section D) |
THE SPECTRANETICS CORPORATION |
9965 federal drive |
colorado springs CO 80921 |
|
Manufacturer Contact |
barbara
creel
|
9965 federal drive |
colorado springs, CO 80921
|
719447-246
|
|
MDR Report Key | 7546805 |
Report Number | 1721279-2018-00066 |
Device Sequence Number | 1 |
Product Code |
DRB
|
UDI-Device Identifier | 00813132022990 |
UDI-Public | 00813132022990 |
Reporter Country Code | US |
PMA/PMN Number | K990713 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/01/2005,05/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/25/2018 |
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Physician
|
Device Model Number | 518-018 |
Device Catalogue Number | 518-018 |
Device Lot Number | UNAVAILABLE |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/01/2005 |
Date Report to Manufacturer | 01/10/2005 |
Date Manufacturer Received | 05/04/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 0 |
Treatment | SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Other;
Required Intervention;
|
Patient Age | 27 YR |
Patient Weight | 54 |