Brand Name | SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER |
Type of Device | CATHETER, PERIPHERAL, ATHERECTOMY |
Manufacturer (Section D) |
THE SPECTRANETICS CORPORATION |
9965 federal drive |
colorado springs CO 80921 |
|
Manufacturer (Section G) |
THE SPECTRANETICS CORPORATION |
9965 federal drive |
|
colorado springs CO 80921 |
|
Manufacturer Contact |
barbara
creel
|
9965 federal drive |
colorado springs, CO 80921
|
|
MDR Report Key | 12694434 |
MDR Text Key | 282712669 |
Report Number | 1721279-2021-00196 |
Device Sequence Number | 1 |
Product Code |
MCW
|
UDI-Device Identifier | 00813132024697 |
UDI-Public | (01)00813132024697(17)230709(10)FBD21F29A |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K170059 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
09/27/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/09/2023 |
Device Model Number | 410-152 |
Device Catalogue Number | 410-152 |
Device Lot Number | FBD21F29A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/13/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/27/2021 |
Initial Date FDA Received | 10/25/2021 |
Supplement Dates Manufacturer Received | 11/05/2021
|
Supplement Dates FDA Received | 11/09/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/29/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 2ND TURBO ELITE DEVICE TO COMPLETE CASE; ABBOTT 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH |
Patient Age | 71 YR |
Patient Sex | Male |
Patient Ethnicity | Hispanic |