Brand Name | CAPTIVATOR II |
Type of Device | SNARE, FLEXIBLE |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
2546 calle primera |
propark, coyol |
alajuela |
CS
|
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 15990515 |
MDR Text Key | 308379258 |
Report Number | 3005099803-2022-07243 |
Device Sequence Number | 1 |
Product Code |
FDI
|
UDI-Device Identifier | 08714729855903 |
UDI-Public | 08714729855903 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K133987 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/15/2022 |
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 Model Number | M00561221 |
Device Catalogue Number | 6122 |
Device Lot Number | 0029942899 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/21/2022 |
Initial Date FDA Received | 12/15/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/12/2022 |
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 |
|
|