Brand Name | COPILOT® BLEEDBACK CONTROL VALVE |
Type of Device | ACCESSORIES |
Manufacturer (Section D) |
ABBOTT VASCULAR |
26531 ynez rd. |
temecula CA 92591 4628 |
|
Manufacturer (Section G) |
ABBOTT VASCULAR, REG # 2024168 |
26531 ynez road |
|
temecula CA 92591 4628 |
|
Manufacturer Contact |
lindsey
bell
|
26531 ynez rd. |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 19134514 |
MDR Text Key | 340924114 |
Report Number | 2024168-2024-04818 |
Device Sequence Number | 1 |
Product Code |
DTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K991102 |
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 |
Report Date |
04/18/2024 |
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 Catalogue Number | UNKNOWN COPILOT BBC |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/02/2024
|
Initial Date FDA Received | 04/18/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 | .014 GUIDE WIRE.; BALLOON CATHETER.; GUIDING CATHETER. |
Patient Age | 60 YR |
Patient Sex | Male |
Patient Weight | 101 KG |