Brand Name | CLARIVEIN IC INFUSION CATHETER |
Type of Device | CLARIVEIN IC INFUSION CATHETER |
Manufacturer (Section D) |
VASCULAR INSIGHTS LLC |
1 pinehill dr. |
two batterymarch park |
quincy MA 02169 |
|
Manufacturer (Section G) |
CONTRACT MANUFACTURED FOR VASCULAR INSIGHTS LLC |
1 pinehill dr. |
two batterymarch pk suite 100 |
quincy MA 02169 |
|
Manufacturer Contact |
paul
piselli
|
1 pinehill dr. |
two batterymarch pk. suite 100 |
quincy, MA 02169
|
2034465711
|
|
MDR Report Key | 7610940 |
MDR Text Key | 111393234 |
Report Number | 3005831739-2018-00035 |
Device Sequence Number | 1 |
Product Code |
KRA
|
UDI-Device Identifier | 10854339004034 |
UDI-Public | (01)10854339004034(10)BM85E140S0218I(17)210111 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153502 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Remedial Action |
Patient Monitoring |
Type of Report
| Initial |
Report Date |
06/15/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/11/2021 |
Device Model Number | 85-018-E140S |
Device Catalogue Number | N/A |
Device Lot Number | BM85E140S0218I |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/31/2018 |
Initial Date FDA Received | 06/18/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|